The Research\ Studies section starts with an article on CES and chi, homeostasis and the bioelectrical system

The Research\ Studies section starts with an article on CES and chi, homeostasis and the bioelectrical system. Following this are some articles by

Ray Smith, Ph.D. that are recently completed summary studies or meta-analyses of different cogent CES topic areas. Following these articles are broad range database literature search results. I hope you enjoy these readings.

Charles McCusker, Ph.D. June 2006

Cranial Electrotherapy Stimulation (CES), Chi,

Homeostasis, and the

Bioelectrical System

Charles McCusker, Ph.D., Nicholas Mason, Ph.D.,

Eldon Taylor, Ph.D., and Lawrence Paros, Ph.D.

Chi is you, Chi is me (ancient proverb)

Optimal mental and emotional functioning depends on the whole body. Chi or vital force can be looked at in terms of its components as well as we might define them according to the measures and means (science with its language) that we want to do so. It depends especially on the brain. Our bodies have an elaborate system of checks and balances. This elaborate system protects the brain from changes in temperature, acceleration, and chemistry.

The current state of knowledge of bioelectrical systems is limited, as it is in many areas of biology. At the present time there is no uniform agreement on the mechanisms of action of CES (Cranial Electrotherapy Stimulation). To proclaim a model can be problematic because the paradigms are evolving very quickly these days.

Physiology

Physiology can be regarded as an aspect of Chi or Vital Force and so accordingly, the evidence of CES effectiveness in this domain is empirical. It is generally believed that the effects are primarily mediated through a direct action on the brain at the limbic system, the hypothalamus and/or reticular activating system. The primary role of the reticular activating system is the regulation of electrocortical activity. These are primitive brain stem structures. The functions of these areas and their influence on our emotional states have been mapped using electrical stimulation. Electrical stimulation of the periaqueductal gray matter (PAG) has been shown to activate descending inhibitory pathways from the medial brainstem to the dorsal horn of the spinal cord, in a manner similar to endorphins. Cortical inhibition is a factor in the Melzack-Wall Gate Control theory.

It is possible that CES may produce its effects through parasympathetic autonomic nervous system dominance via stimulation of the vagus nerve (CN X). Other cranial nerves such as the trigeminal (CN V), facial (CN VII), and glossopharyngeal (CN IX), may also be involved. Electrocortical activity produced by stimulation of the trigeminal nerve has been implicated in the function of the limbic region of the midbrain affecting emotions. Substance P and enkephalin have been found in the trigeminal nucleus, and are postulated to be involved in limbic emotional brain factors. The auditory-vertigo nerve (CN VIII) must also be effected by CES, accounting for the dizziness one experiences when the current is too high. Ideally, CES electrodes are placed on the ear lobes because that is a convenient way to direct current through the brain stem structures.

Neurotransmitters

Brain chemistry and how it works is another important aspect of chi or vital force, and includes nurturance and operation. We call the chemicals which the brain use to operate neurotransmitters. Each neurotransmitter has many functions. Neurotransmitters also have specific effects. Research has especially implicated serotonin in sleep, dopamine in euphoria, endorphins in pain control, and norepinephrine in depression and manic-depressive mood swings. Ordinarily these and other substances interact to maintain a balance for optimal physical, intellectual, and emotional well being.

On the cellular level, as well as intercellular and organic as well as interorganic systemic level we call this state homeostasis. For example, in the brain the levels of the above mentioned neurotransmitters have been demonstrated in published literature to be at certain levels with individuals demonstrating normal ranges of psychological and behavioral functioning in everyday living, whereas individuals with certain types of diagnosed pathologies, most noted and frequently measured in the literature being depression and anxiety related disorders, as well as individuals suffering from serious types of chemical dependencies.

Homeostasis

The notion here is that CES usage improves the homeostasis state or within its domain provides for a state of optimal homeostasis. Homeostasis is here defined as maintaining .... functions within very narrowly defined ranges. The body's ability to preserve the critical balance of its internal environment, regardless of external changes, is essential for its survival. Our body (including and especially the brain) reacts to changes in our environment. It constantly works to preserve optimal functioning as a whole which is defined as homeostasis or a homeostatic state. Its response and interaction with the environment is dynamic and continual, operating at many levels some within conscious awareness and many out of the range of our conscious perception. An example of a biological process not in a continual awareness state would be the digestion of food. Certainly we may respond to or be aware of eating, although after vigorous physical labor we may see the grand spread of food before us and wolf it down, not paying particular attention to savoring each tasty morsel, but eating quickly because our stomach says feed me .

So we choose at some level to be partially only partially conscious of the sensation of taste because the biological requirement of providing energy to fuel the body (remember, survival first ) blocks the more sensate focus of enjoying each tasty morsel of food. This is adaptive and common sense that most of us understand on a very basic level.

Continuing with this example, much less conscious awareness would typically be available to the digestion process, this process where food is broken into useful and usable components is something we don't pay much attention to, it is relatively automatic. Imagine how maladaptive it might be to be consciously contemplating and focusing in the digestion process while driving down a road on the side of a mountain while in the middle of a blizzard. Under these circumstances driving off the side of a mountain while consciously focusing on digestion of our lunch could be much less adaptive than keeping our eye (and corresponding muscle and bodily movements) attending to staying on the road and successfully completing the task of driving to our destination.

Events we might define as stressful can alter our body systems to change its homeostasic range, which can be adaptive for that moment. The startle response and body reaction to manipulate our motor vehicle seeing a deer running out in front of us to stay on the road and hopefully not injure the animal can change the bodily homeostasis while in this situation. After this event the various systems react to bring it back, that is alter the balance back to the regular driving the vehicle mode.

Ecotropic

The term Ecotropic refers to creating a balanced inner environment in a person, cures rather than ameliorates, has multilevel and multidisciplinary integrity, creates an environment for growth, deals with effects at the level of cause, encompasses a wide spectrum, is dynamic in its innovation, is harmless with only positive side effects , deals directly with the structure of the being, ecological - holistic - does not harm, creates consciousness, aids in creating an individual homeostasis state directly related to more authentic (real) being - again multilevel brain chemistry, cognitive, psychodynamic - energy in a body, wide spectrum, deals with effects at the level of cause, creates an environment for growth, creates a balanced inner environment within a person.

Pressure and Stress

Efforts, challenges, threats, or perceived threats or damage (physical and/or psychological) puts pressure on our biosystem. We thrive on various pressures to experience, adapt, survive, learn, and to live. Muscles can develop from putting pressure on them and they will atrophy without that work. The same principle applies throughout our physical system, and our brain as well (emotion and intellect). We depend on pressure and grow by challenging ourselves. We will define healthy systemic pressure as eustress. This is differentiated from what we commonly call stress. In engineering terms the concept of stress say on a steel I beam in a high rise building can lead to metal fatigue and the actual physical breaking of that beam, which could potentially lead to the breaking and even collapse of that building. We will follow the convention of using stress to mean bad stress. Despite this, please regard stress as basically good. People can subject themselves to so much exercise that they loose strength and endurance. They use up their muscle tissue faster than they rebuild it. Then the healthy stress on their muscles becomes destructive.

Chemically, we need adrenaline and choline systems, adrenergic and cholinergic systems. We need our bodies’ hormonal systems to use and build our muscles. The body's hormonal systems also keep a homeostatic balance.

Psychological Distress

In psychological stress, the body shifts into the fight or flight mode. Our body prepares for immediate physical action. These systems too can suffer atrophy or exhaustion. We can directly see and feel the body’s responses to some kinds of stress. We sweat and flush from muscular effort; we get goose bumps and pale skin from cold. We can even hear fatigue or shivering in a person’s voice.

Insensible Stress

Primarily hidden symptoms accompany the shift from benign to pathological stress. We cannot so easily see, hear, or feel sleeplessness, irritability, and inability to concentrate. For most of us, only mechanical medically related instruments reveal blood pressure gradually elevating to dangerous levels, and body chemistry going out of balance. Sometimes the body cannot maintain the range of temperature necessary for adequate functioning. Sometimes people persist in exercising, working, or even playing to exhaustion. Either can lead to collapse and eventual death. The body also suffers other types of collapse when other types of stress press it beyond its limits.

When under stress, the brain shifts its transmitter balance. This prepares the body to deal with the stress. If the stressing agent remains present (stressful conditions on the job, in the home, etc.) the shift may become permanent. The body and the personality of the individual can suffer from such permanent shifts away from healthy homeostasis. This brings patients to medical treatment facilities.

Stressors

Almost anything can cause stress. Identification as a stressor depends as much on interpretation as on substance. Being around strange people, loud noises, fast cars, and unfamiliar situations all cause stress reactions. Until the middle of this century, life accustomed us to small farms with a cow, maybe a goat, and three chickens. People went to bed when the sun set, got up when it rose, and had acquaintances whom they met every day of their lives.

Many people still live rural lives today. Such people do not regard themselves as having extended families and close communities. They regard us as having truncated families and splattered communities. Now we live in today's metroplex society. We drive on crowded highways, live in high rise buildings, and work with multitudes of strangers. The media present murders, rapes, and other violence, real and imagined, continuously. All these can and do cause the fight or flight response. All these can cause excessive stress.

Stress control programs have proliferated. Most work from assuming, Stress is bad. They teach stress reduction. A few actually teach stress management. Some teach conscious skills, often with cassette tapes or counselors. Sometimes these skills become habits. The body responds gradually. Other programs more directly address the body. They may include muscle balancers and toners, flotation tanks, massage, exercise, and more physical interventions. In these therapies, the body responds directly and the neurotransmitters of the brain respond gradually.

The most effective and efficient programs address both the body and the brain simultaneously. This establishes a balanced body-mind relationship. This approach has the added benefit of potentiation.

Potentiation

Some synergy always exists between the various factors in a situation. A small company made of similar people has a much lower chance of success than a similar company made of people who have different skills and experiences and preferences. Work done on the body, work to alter the brain's neurochemistry, and work with cognitive skills all abet each other.

Medications used separately may have nearly harmless effects. Used together, these same medications will have effects greater than the sum of their independent effects or different than those taken individually. In a negative sense these are commonly referred to as side effects and this term usually connotes as just stated, negative effects. Alcohol has become notorious for this. Potentiation demands that we use interventions with no harmful effects.

In the past, potentiation has been regarded almost exclusively as a problem. By combining exclusively benign interventions we can take advantage of it. We regard it as valuable. Our lives are a continuous process of potentiation.

The Body-Brain Continuum

Chi is dynamic. Our emotions, intellects, cognitive mind sets, perceptions, physiologies, chemistries, and much more all overlap and interact to make who we are. Simple examples can illustrate this complexity. A change in the environment can cause a hormonal shift. An argument causes a stress response - fight or flight. Such shifts, if repeated and inappropriate, can lead to a hormonal imbalance. Very few arguments could justify punching or running away from your opponent. People have a lot of arguments. They might have a lot of inappropriate responses to a lot of different stressors. This leads to changes, from subtle to dramatic, in the normal body functions.

Running could do you some good. Better yet, avoid people with whom you might have unpleasant arguments. Suppose you have excellent vision. You could easily avoid those people. You would see them before they saw you. Have you ever been nearsighted? Nearsighted people often squint to see farther. This tends to produce a characteristic facial expression. More, the pectoral muscles in their chest tend to contract in a reflexive effort to draw them nearer their point of optimum focus. They can become round shouldered or even somewhat hunchbacked.

Disturbing the normal functional relationship between the muscles, bones, tendons, ligaments, and other structures of the body leads to changes in the biochemistry of the brain. Painful or dysfunctional joints and muscles can turn the individual into a wounded animal that needs gentle handling. This hyperirritability reflects changes in the neurohormonal system of the brain.

The Role of CES

CES means to apply low voltage, low amplitude, pulsed current transcranially. It pulses 100 times per second (there are other frequencies as well, of course) on a twenty percent duty cycle. The pulse wave is a modified square wave with no D.C. bias (meaning that the pulse goes back and forth equally across the head, instead of pulsing more left to right or more right to left). Small rechargeable batteries provide the current. The device limits the stimulus to approximately 1.5 mA or less. CES has proven an effective prescription for the treatment of many debilitating pathologies. Improved cognitive function has also been demonstrated in terms of improved cognitive skills. This can certainly be considered an aspect of chi or vital force.

How CES Works.

Acetysalic acid, and its pharmacological ancestor, salic acid, had proven benefits long before we had any idea how they worked. We call it aspirin. CES has this in common with aspirin. Unfortunately, CES has not been marketed on a wide spread basis such as aspirin.

We have begun to learn how CES produces its effects. Earlier studies on animals led researchers to postulate that CES has its effects in the hypothalamic center of the brain, and possibly in other primitive or emotion control centers within the brain. CES now appears to have its effect by stimulating the brain generally. This increases the brains manufacture and use of neurotransmitters, that leads to a homeostasis of brain biochemistry, another aspect of chi.

Cortical Learning

Our bodies can learn outside our awareness, and possibly independently of our brain. This has received notice as visceral learning . Similarly, our brains can learn responses outside our awareness. This would certainly apply to the amelioration of chi with CES stimulation. Laboratory experiments have even conditioned individual neurons to respond to receive molecules of cocaine. Obviously, networks of neurons can develop more complex responses.

Only immediate and detectible stimuli have a conditioning effect. Few people enter prolonged depression suddenly. A person may slowly sink into depression. It usually happens in slow small steps, often times undetectable consciously. Most efforts to relieve depression will result in at least some immediate unpleasantness. So they sink.

Suppose that using a particular network of neurons has immediately unpleasant results. The brain may soon learn not to use that network. Only a part of the network caused problems. Even that could have been repaired. The brain does not know that. Hence we may learn to forget an event or even whole skills associated with unpleasant feelings. Intuitively, it seems that taking parts of the brain off line could explain some pathology.

Why CES works

Cranial electrotherapy stimulation (CES) stimulates, rather than directs, the general function of the brain (effect on chi with an application of an external energy force). It gently adds energy diffused to essentially all parts of the brain. As a result, each part can more readily perform at optimum levels. Some parts of the brain manufacture neurohormones. They can turn off or on more readily. This brings the neurohormones to homeostasis. This brings the harmony that would exist if we freed ourselves from distress or other damage.

Normally the amount of one neurochemical in the brain influences manufacture of others. In turn, the amount of one or more of the other neurotransmitters act as a check on the production and use of the first neurotransmitter. This interaction reestablishes the check and balance system which maintains homeostasis.

The task of CES is to bring the brain to a healthy homeostatic condition. With this accomplished, CES has no additional effect. In this regard CES is not habit forming nor addictive.

How Long Does CES Need To Take Effect?

Most individuals respond within several minutes of wearing a CES device. They may immediately report relaxation, relief from pains, more energy, or an increased ability to concentrate. Some notice positive changes over time. Others can wear a CES device for days or weeks and not notice. This may stem from a lack of awareness.

Obstacles to CES

Two common factors can cut the effects of CES. The brain may lack what it needs to improve its function, and the brain may have something blocking its function. These can mask or prevent or mask the benefits of CES. A poor diet seems the most common cause. The brain's blood supply may lack the chemical precursors for the neurotransmitter(s) it needs to produce. CES stimulates brain centers that produce these chemical precursers to produce some neurotransmitters. Neurons cannot manufacture the neurotransmitters without the building blocks of those neurotransmitters present in the bloodstream.

Conversely, pathogens might override the new neurochemical response. A virus can divert resources to the immune system. Using cocaine can deplete norepinephrine faster than CES can stimulate its renewed production. Even having coffee or chocolate (caffeine), or a few beers (alcohol), before bedtime can override natural sleep induction by serotonin.

In both cases, clients must improve living habits. This leads to the further benefits of potentiation. Allow for these exceptions.

Common Applications of CES

Granted these exceptions, CES proves effective in many applications. In the western culture depression and anxiety seem the most common psychological problems of normal people in normal life. In both cases, clinicians distinguish between reactive and obscure pathology. Reactive pathology grows from an event. People feel anxiety when loved ones might die, and depression when bereaved. We label such normal feelings pathological when they persist past social norms and prevent normal productive behavior. In the Eastern culture flow of an improvement in oneness realization and improvement of chi and mastery could be emphasized. This would of course include an improved ability to learn and do.

In the western world obscure pathology has no apparent relationship to any specific event. It generally has a longer history and takes longer to respond to therapy. CES can alleviate reactive depression or anxiety in about a week with one forty-five minute session per day. More severe depression and/or anxiety requires three to five weeks or more of one or more forty-five minute daily sessions in its amelioration. In the Eastern world effect would likely be seen as an improvement in capacity or a strengthening of chi or vital force can be often immediately experienced with CES but can certainly take four to six weeks or longer of regular CES usage.

Other Therapies with CES

Many individuals receive CES as part of additional treatment programs. They usually enter the treatment program as a result of living in an environment that over stressed them. Their coping mechanisms, both physical and psychological, have failed.

Typically, these patients receive therapy, stress reduction and stress management training. During the course of treatment for outpatients, or following treatment for inpatients, they enter a non-therapeutic environment. This often requires some initial support. CES can has proven useful for preventing a recurrence of pathology.

People can learn more quickly when their being (at different levels) is improved. People can heal and learn much more easily when free from stress. The stress response makes any but the most immediate and reflexive learning difficult. Learning relaxation despite stress has proven particularly difficult. This difficulty also blocks healing. CES can free us from the effects of the stress response. We can learn anything, especially relaxation, better and faster.

The Role of Nutrition

Think of a typical car battery. It won't start your engine. You test the cells. It has three dry cells. The battery requires two factors to reestablish normal function. You must add water and at least a trickle charge of electricity. Similarly, the necessary nutritional elements as well as the trickle charge combine to reestablish normal affectively related cognitive function.

We get amino acids from food. Amino acids in the blood serve as precursors for neurohormones. That means the brain uses these amino acids to build neurohormones. The brain can do this much more efficiently when accompanied by CES treatment.

Cognitive Changes related to CES Intervention Charles McCusker, Ph.D. 12/7/05

These studies were conducted by Charles McCusker, Ph.D.& Delbert T. Goates, M.D. from 1992 to 1996 (unpublished manuscript) and the component of the data shown here describes the positive cognitive change results of CES for psychiatric outpatients. Our earliest formal case histories yielded the following cognitive data.

The Wechsler Adult Intelligence Scale-Revised (WAIS-R), with a sample size of 25:

Probability of IQ scores change due only to test-retest practice effects

Verbal Performance Full Scale practice effects

pre 101.6 107.2 104.12 p < .0001

post 110.0 122.12 116.52 p < .0001

difference +8.4 +14.92 +12.40 p < .0001

Verbal Subtest scores

Informa- Digit Vocab- Arith- Compre- Similari-

tion Span ulary metic hension ties

pre 9.4 10.0 10.8 9.4 10.8 9.5

post 10.0 10.0 12.0 10.4 12.5 11.1

difference +.6 0 +1.2 +1.0 +1.7 +1.6

Performance Subtest scores

Picture Picture Block Object Digit

Completion Arrangement Design Assembly Symbol

pre 10.6 10.4 10.3 9.6 8.7

post 12.1 12.0 12.1 13.0 10.5

difference +1.5 +1.6 +1.8 +3.4 +1.8

The WAIS-R scores displayed statistically significant (p<.0001) changes between pre- and post- treatment IQ, as well as positive changes in ten of eleven subtests on the same measure.

Quantum theory predicts and experiments have verified that so-called empty space (the vacuum) contains an enormous residual background energy known as zero-point energy ( ZPE). ZPE is derived from the fact that at temperatures of absolute zero (- 273^o Celsius) elementary particles continue to exhibit energetic behavior. Theoretical advances of zero-point energy, nonlinear thermodynamics, and connective physics open the practical purpose application of ZPE - in essence tapping the zero-point, and thereby accessing a universe sized source of energy.

Theoretical contributions have been done by such pioneers as Nobel laureates Ilya Prigogine, P. A. M. Dirac, John Wheeler, and Julian Schwinger. Prigogine, for example, has shown that the second law of thermodynamics can be expanded to include systems in which order evolves from randomness. This result has also been obtained by Puthoff who utilized theories of ZPE to obtain an equivalent result. The critical factor here is that linear systems tend toward increasing entropy (i.e. the result of two inputs being the sum of their corresponding outputs), whereas under certain conditions nonlinear systems have been shown to evolve toward macroscopic order. Such nonlinear systems imply transient or apparently uncontrolled systems, but the reality remains that clever designs can and do provide means to skirt traditional understandings of thermodynamic limitations and literally tap into the surrounding universe for unlimited amounts of useful energy.

It is sometimes assumed that the era of overunity energy research began with the pivotal work of Pons and Fleischman in their discovery of what came to be referred to as cold fusion. While the possibly premature nomenclature of “fusion” might not be strictly applicable, Patterson has taken this work even further, achieving significant results in both energy production and the transmutation of elements. In many respects, while this work cannot be overestimated in its profound importance to a better understanding of physics and chemistry, it nevertheless has shown greater potential for the transmutation of elements than it has for energy production as demonstrated in the work of Pappas at the University of Athens and his “cold fusion” model of cellular level sodium to potassium conversion.

This has dramatic implications in beginning to understand that the application of CES field energy to a mass would have some predictable and measurable effect. According to the laws of quantum physics therefore, Chi can be predictively increased.

(Special acknowledgments and thanks for the inspiration from the authors to Elizabeth Lindsey; Mette Lindsley; N; Ravinder Taylor; Aram V. Tanielian; and Marilyn Whimpey, B.S.)

References

Readers are advised to look below at the other articles and literature searches to find a plethora of CES references.

A Summary Look at CES Studies of Addiction

By Ray B. Smith, Ph.D.

Executive Summary. Fifteen studies were analyzed, in which a total of 535 patients were treated for the substance abstinence syndrome with cranial electrotherapy stimulation (CES). The studies were combined statistically in order to get a more confident look at the effectiveness of CES for treating this condition. While most of the studies were of the classic double blind protocol, others used either the single blind or open clinical trial. The result of the analysis showed that the overall effectiveness of CES was 60% improvement. Elsewhere it has been noted (see cognitive dysfunction studies) that the “permanent brain damage” that was said to be a condition of long term substance abuse patients as late as the 1980s, has now been seen to return to within normal functional limits following 3 weeks of daily CES treatment.

Introduction

Meta-analysis is a way of combining the results of many separate studies to see the effectiveness of a treatment when different types of patients are studied, under different study conditions, with different study protocols, and who came to the various studies with differing symptoms accompanying their drug withdrawal.

The goal of clinical studies is always to first test the effectiveness of a potential treatment and secondly to discover which patients the treatment may be most effective in treating. Meta-analysis has the effect of allowing us to essentially study a larger number of patients than can usually be assembled for a single study, and the larger the combined study sample, the greater is the confidence that can be placed in the study outcome: that the study findings are true and accurate. Also, the more diverse the study group is in the combined sample, the more confident can we be in generalizing the study outcome to larger groups of people outside the study. That is, it increases the range of potential types of substance abuse patients that we can predict will be effectively treated with CES.

In the table below is a summary of 15 studies that were combined into the meta-analysis reported on here.

Studies of the Drug Abstinence Syndrome with CES

Study Design

Zr Score^a

Presenting

Group

No. Subjects

Measure Used^b

Reference

Double Blind

.987

Poly Substance

Withdrawal

Clinical Rating Scales

Double Blind

.397

Cocaine Withdrawal

Treatment Responses

Double Blind

1.029

Methadone Withdrawal

Treatment Records

Double Blind

.415

Alcohol Withdrawal

Self and Clinical Rating Scales

Double Blind

.403

Alcohol Withdrawal

Self and Clinical Rating Scales

Double Blind

.780

Poly Substance Withdrawal

Psychological Tests

Double Blind

.671

Poly Substance Withdrawal

Self Rating Scales

Totals

4.682

212

Average

.669

Effect Size^c

r = .58

Single Blind

.360

Alcohol Withdrawal

Psychological Tests

Single Blind

.772

Alcohol Withdrawal

Self Rating Scales

Single Blind

.725

Alcohol Withdrawal

Self Rating Scales

Single Blind

.737

Alcohol Withdrawal

Self Rating Scales

Totals

2.594

203

Average

.649

Effect Size

r =.57

Open Clinical

.678

Alcohol Withdrawal

Physiological Measure

Open Clinical

.775

Smoking Cessation

Reduced Smoking

Open Clinical

.549

Poly Substance Withdrawal

EEG

Open Clinical

1.065

Marijuana Withdrawal

Self Rating Scales, Physiological Measure

Totals

3.067

120

Average

.767

Effect Size

r =.65

SUMMARY, ALL ADDICTION STUDIES REPORTED ABOVE

Grand Total

10.343

535

Average

.690

Total Effect Size

r =.60

^a Most studies utilized several (up to 7) improvement measures, and since different percent improvement scores can not legally be averaged, they are converted into Zr scores, averaged, and then converted back to an overall percent improvement (effect size), with the average improvement on all measures reported for each study.

^b The Self Rating and Clinical Rating Scales used in the studies all have published reliability and validity measures.

^c Effect size, here, is a statistician’s basic estimate of the overall percentage improvement by the patients as a result of the treatment

Discussion

The variety of substances of abuse involved in the above studies were quite varied, and included alcohol, heroin, cocaine, marijuana, and nicotine, among possibly others hidden within the poly substance groups. The measures used in evaluating the response to treatment were also greatly varied. Some involved published clinician’s ratings scales, other utilized published patient’s self rating scales, while others used psychological tests of various kinds, while yet others combined these along with physiological measures, such as EEG or EMG recordings. While in one study a clinician’s rating of treatment response was among the lower measures obtained, in another study the analysis of patient records, both during and following treatment, was among the highest. Also among the strongest responders to the CES treatment were methadone and marijuana patients.

Two of the studies compared the treated and control patients on AMA rates in which the patients left the program against medical advice, and on recidivism rate which measures the number of times a patient returns for additional treatment. In both cases, they found that both the AMA and recidivism rates were reduced by one-half or more in the treated patients.^2,7

Researchers earlier received a strong impetus to study CES in substance abuse patients when in the 1970s it was found that the abstinence syndrome, including such features as depression, anxiety and insomnia, was seen to come under control very quickly with CES. Serendipitously it was also discovered that what had up until the 1980s been termed “permanent brain damage” in these patients responded to three weeks of CES treatment by bringing these patients back within their normal functioning range. (See the analysis of cognitive function studies presented elsewhere.)

A word about the study types. In the open clinical study, the patients know they are being actively treated for the abstinence syndrome, the clinicians know who is being treated, and the statistician who summarizes the study data also knows, since there is only one group of patient records to analyze.

In the single blind study, the patients do not know which are getting treated and which are getting sham treatment, but the clinician providing the treatment knows which are the treated patients. In the single blind study, the clinician doing the post study evaluation of the patients is often blinded to treatment conditions when he completes his evaluation. The statistician is usually blinded also, so that he is given two sets of scores to compare, and doesn’t know which group received the treatment. This study design was used earlier on before treatment blinding devices came on stream. In such studies, the treatment was administered sub sensation threshold, in which the clinician turned up the current intensity until the patient just felt it, then turned it back down until the patient said he could no longer feel the stimulation. At that point, the clinician either left the current at that level or turned the unit off (down to, but not including the final click). Because both the patients and the statistician are both blind to the study conditions, some authors have unwittingly published this design as a double blind experiment. But that term is generally reserved for the true double blind experimental design as described next.

The double blind study, the gold standard of science, is usually confined to studies in which neither the patient nor the clinician knows who is being studied. Those designs became available when a double blinding box could be inserted between the patient and the CES device. The double blinding box often had three, four or more settings in addition to a “0” setting in which current flowed freely between the CES unit and the patient. Among the other settings available, some passed current to the patient and some blocked it entirely. The clinician would begin the double blind treatment session by setting all double blinding boxes to the “0” position, would connect the patient to the CES electrodes, turn the current up slowly until the patient signaled he could just feel it, then reduce the stimulus level until the patient signaled that he could no longer feel it. At that point, the clinician set the double blinding box to one of the other settings available and left the patient on the device for 30 minutes to an hour, not knowing who was receiving actual treatment.

Interestingly, in a good double blind experimental design, such as was the case in the majority of those reported in the table above, the persons who were responsible for measuring or rating patient improvement were also blind as to who was treated, as was the statistician who was given anonymous groups of data to analyze. Note that, in effect, that makes such studies quadruple blind, but that term is not used in science.

In the crossover design, half the patients get treated the first week or two of the study, while the other half receive sham treatment. In the second half of the study, the formerly treated patients now receive sham treatment while the formerly sham treated patients receive treatment. If the crossover does not involve a sham treatment condition, then the crossover study is treated as an open clinical trial where all patients and staff know who is being treated at each cross of the study. That design is often referred to as a study with “wait in line” controls, in that the patients waiting to begin treatment are tested before and at the end of the waiting period before going into treatment. That is thought to control for environmental factors such as unusual stressors on the 10 O’clock news, any local dramatic weather changes, and so forth.

Interestingly we learned early on in CES work to stay clear of the cross over design in CES studies, after we discovered that the improvement begun by a week or so of CES treatment can often continue after treatment is stopped. That is, the patients continue to get better as time goes on following treatment. One can imagine what that does to the statistical analysis when at the end of the study both groups have improved significantly, but the patients treated first are no longer behaving as good controls should, but are getting even better than the final treatment group is showing. Many otherwise good studies were lost early on due to that effect, and one can see in the table above that the crossover design was wisely avoided in all of the studies reported.

Safety

It is interesting to note that not one problem from negative side effects has ever been reported in any published CES study. Patients undergoing withdrawal for substance abuse are sometimes prone to experience withdrawal seizures. None of the patients undergoing withdrawal in which CES is used has ever been reported to have had a seizure.

One interesting clinical detail we learned early on is that patients who have not been sleeping well when they enter a study – many of them, by definition – sometimes make up for lost REM sleep during CES treatment and have the most vivid, most colorful dreams they have ever had. We learned to warn study participants of this in advance, since some earlier patients associated this with incipient schizophrenia or some other serious mental condition. Once alerted to the possibility they have always looked forward to the effect with real anticipation.

References

1. Bianco, F. (1994) The efficacy of cranial electrotherapy stimulation (CES) for the relief of anxiety and depression among polysubstance abusers in chemical dependency treatment. Ph.D. dissertation, The University of Tulsa.

2. Brovar, A. (1984) Cocaine detoxification with cranial electrotherapy stimulation (CES): a preliminary appraisal. International Electromedicine Institute Newsletter. 1(4):1-4.

3. Gomez, E. and A.R. Mikhail (1978) Treatment of methadone withdrawal with cerebral electrotherapy (electrosleep) British Journal of Psychiatry. 134:111-113.

4. Krupitsky, E.M., A.M. Burakov, G.F. Karandashova, J.S. Katsnelson, V.P. Lebedev, A.J. Grinenko, and J.S. Borodkin (1991) The administration of transcranial electric treatment for affective disturbances therapy in alcoholic patients. Drug and Alcohol Dependence. 17:1-6.

5. McKenzie, R.E., R.M. Costello, and D.C. Buck (1976) Electrosleep (electrical transcranial stimulation ) in the treatment of anxiety, depression and sleep disturbance in chronic alcoholics. Journal of Altered States of Consciousness. 2(2):185-196.

6. Schmitt, R., T. Capo, H. Frazier, and D. Boren (1984) Cranial electrotherapy stimulation treatment of cognitive brain dysfunction in chemical dependence. Journal of Clinical Psychiatry. 45:60-063.

7. Schmitt, R., T. Capo, and E. Boyd (1986) Cranial electrotherapy stimulation as a treatment for anxiety in chemically dependent persons. Alcoholism: Clinical and Experimental Research. 10(2):158-160.

8. Smith, R.B. (1982) Confirming evidence of an effective treatment for brain dysfunction in alcoholic patients.Journal of Nervous and Mental Disease. 170:275-278.

9. Smith, R.B. and L. O’Neill (1975) Electrosleep in the management of alcoholism. Biological Psychiatry. 10:765-680.

10. Smith, R.B., and L. O”Neill (1975) Electrosleep in the management of alcoholism. Biological Psychiatry.10(6):675-680.

11. Weingarten, E. (1981) The effect of cerebral electrostimulation on the frontalis electromyogram. Biological Psychiatry. 16(1):61-63.

12. Smith, R.B., A.E. Burgess, V.J. Guinee, and L.C. Reifsnider (1979 A curvilinear relationship between alcohol withdrawal tremor and personality. Journal of Clinical Psychology. 35(1):199-203.

13. Boertien, A.H. (1967) The electrosleep apparatus as a device in an antismoking therapy. In: Wageneder, F.M. and St. Schuy (Eds) Electrotherapeutic Sleep and Electroanaesthesia. Amsterdam: Excerpta Medica Foundation. International Congress Series No.136 pp. 103-104.

14. Braverman, E., R.B. Smith, R. Smayda and K. Blum (1990) Modification of P300 amplitude and other electrophysiological parameters of drug abuse by cranial electrical stimulation. Current Therapeutic Research.48(4):586-596.

15. Overcash, S.J. and A. Siebenthall (1989) The effects of cranial electrotherapy stimulation and multisensory cognitive therapy on the personality and anxiety levels of substance abuse patients. American Journal of Electromedicine. 6(2):1050-111.

A Summary Look at CES Studies Of Anxiety

By Ray B. Smith, Ph.D.

Executive Summary. Thirty-eight studies were analyzed, in which a total of 1,495 patients were treated with cranial electrotherapy stimulation (CES) for anxiety. The patients had presented with various clinical syndromes, of which anxiety played a major part. The treatment outcome anxiety scores were combined statistically in order to get a more confident look at the effectiveness of CES for treating this condition. While the majority of the studies were of the classic double blind protocol, others used either the single blind, the cross over design or were open clinical trials. The result of the analysis showed that the overall effectiveness of CES was an impressive 58% improvement. The results indicated that various types of anxiety, which accompany a wide range of clinical syndromes can be expected to respond, sometimes dramatically to CES treatment.

Introduction

The goal of clinical studies is always to first test the effectiveness of a potential treatment and secondly to discover which patients the treatment may be most effective in treating. Meta-analysis has the effect of allowing one to essentially study a larger number of patients than can usually be assembled for a single study, and the larger the combined study sample, the greater is the confidence that can be placed in the study outcome: that the study findings are true and accurate. Also, the more diverse the study group is in the combined sample, the more confident one can be in generalizing the study outcome to larger groups of patients outside the study. That is, it increases the range of potential types of anxiety patients that one can predict will be effectively treated with CES.

In the table below is a summary of 38 studies that were combined into the meta-analysis reported on here.

CES Anxiety Studies Completed Over the Past 36 Years

Study Design

Zr Score^a

Presenting

Group

No. Subjects

Measure Used^b

Reference

Double Blind

.950

Substance

Abuse

Clinical Rating Scales

Double Blind

.412

Outpatient Psychiatric

Abuse

Self Rating Scale

Double Blind

.365

Substance

Abuse

Self Rating

Scale

Double Blind

.549

Outpatient Psychiatric

Clinical Rating Scale

Double Blind

.720

Outpatient Pain Patients

Physiological Measures

Double Blind

.604

Outpatient Pain Patients

Physiological Measures

Double Blind

.563

Psychiatric Prisoners

Clinical Rating Scale

Double Blind

.625

Substance

Abuse

Self Rating Scales

Double Blind

1.099

Psychiatric Inpatients

Self Rating Scale

Double Blind

.233

Psychiatric Inpatients

Self Rating Scales

Double Blind

.693

Substance

Abuse

Self Rating Scale

Double Blind

.775

Psychiatric Inpatients

Self Rating Scale

Double Blind

.618

Psychiatric Inpatients

Self Rating Scale

Double Blind

.405

Psychiatric Outpatients

Clinical Rating Scales

Double Blind

.365

Substance

Abuse

Self Rating Scales

Double Blind

.693

Closed Head Injured

Self Rating Scale

Double Blind

.549

Normal Volunteers

Physiological Measures

Double Blind

.567

Prison Sex Offenders

105

Self Rating Scale, Physiological Measures

Double Blind

.618

Substance

Abuse

Self Rating Scale

Double Blind

.633

Dental Patients

Self and Clinician Rating Scales

Double Blind

.811

Psychiatric Outpatients

Clinical Rating

Totals

12.847

744

Average

.612

Effect Size^c

r = .55

Single Blind

.497

Substance

Abuse

Clinical Rating Scales

Totals

.497

Average

.497

Effect Size

r =.46

Crossover

.321

Psychiatric Inpatients

Clinician’s Rating

Crossover

.080

Insomnia, Anxiety

Clinician’s Rating

Crossover

.365

Outpatient Psychiatry

Clinician’s Rating

Crossover

1.757

Outpatient Psychiatry

Self, Clinicin’s Ratings

Totals

2.523

Average

.631

Effect Size

r =.56

Open Clinical

.563

Psychiatric Outpatients

Clinician’s Rating

Open Clinical

.523

Psychiatric Outpatients

Clinician’s Rating, Physiological Measure

Open Clinical

.973

Psychiatric Inpatients

Clinician’s Rating

Open Clinical

.621

Graduate Students

Self Rating Scales

Open Clinical

.640

Psychiatric Outpatients

182

Physiological Measures

Open Clinical

1.344

Substance Abuse

Self Rating Scale, Physiological Measure

Open Clinical

.973

Substance Abuse

186

Clinician’s Rating

Open Clinical

.510

Psychiatric Outpatients

Clinician’s Rating

Open Clinical

604

Psychiatric Outpatients

Clinician’s Rating

Open Clinical

1.039

Psychiatric Outpatients

Self Rating Scales

Open Clinical

.436

Phobic Outpatients

Self Rating Scale

Open Clinical

1.099

Prison, Sex Offenders

Self Rating Scale

Totals

9.325

601

Average

.777

Effect Size

r =.65

SUMMARY, ALL ANXIETY STUDIES REPORTED ABOVE

Grand Total

25.192

1,495

Average

.663

Total Effect Size

r =.58

^a r correlation scores, representing percent improvement, are obtained mathematically from the study outcomes presented by the authors. Scores such as percent change scores, statistical probability scores, F scores, t scores, and the like, are changed to r correlation scores and then into Zr scores. That is because percent improvement scores can not legally be averaged. The Zr scores are then averaged and converted back to percent improvement (effect size.)

^b Most of the rating scales, both by the patients and the clinicians were of published reliability and validity. In many of the studies, more than one measure of anxiety was used. In those cases, the average of the results was calculated and reported as the overall result of the study.

^c Effect size, here, is a statistician’s basic estimate of the overall percentage improvement by the patients as a result of the treatment

Discussion

In many of the studies, anxiety was but one symptom within a larger presenting syndrome. For example in many of the patients, fibromyalgia was the presenting symptom, while in another large group of studies the substance abuse (drug abstinence) syndrome was the presenting diagnosis. The presenting syndrome or type of patient is given in column three of the table. In all of the studies, however, anxiety was a major diagnosis within the presenting syndrome or group.

A word about the study types. In the open clinical study, the patients know they are being actively treated for their anxiety, the clinicians know who is being treated, and the statistician who summarizes the study data also knows, since there is only one group of patients.

The double blind study, the gold standard of science, is usually confined to studies in which neither the patient or the clinician knows who is being studied. Those designs became available when a double blinding box could be inserted between the patient and the CES device. The double blinding box often had three, four or more settings in addition to a “0” setting in which current flowed freely between the CES unit and the patient. Among the other settings available, some passed current to the patient and some blocked it entirely. The clinician would begin the double blind treatment session by setting all double blinding boxes to the “0” position, would connect the patient to the CES electrodes, turn the current up slowly until the patient signaled he could just feel it, then reduce the stimulus level until the patient signaled that he could no longer feel it. At that point, the clinician set the double blinding box to one of the other settings available and left the patient on the device for 30 minutes to an hour, not knowing who was getting active treatment..

Interestingly, in a good double blind experimental design, such as was the case in the majority of those reported in the table, the persons who were responsible for measuring or rating patient improvement were also blind as to who was treated, as was the statistician who was given anonymous groups of data to analyze. Note that, in effect, that makes such studies quadruple blind, but that term is not used in science.

In the crossover design, half the patients get treated the first week or two of the study, while the other half receive sham treatment. In the second half of the study, the formerly treated patients now receive sham treatment while the formerly sham treated patients now receive treatment. If the crossover does not involve a sham treatment condition, then the crossover study is treated as an open clinical trial where all patients and staff know who is being treated at each cross of the study. That design is often referred to as a study with “wait in line” controls, in that the patients waiting to begin treatment are tested before and at the end of the waiting period before going into treatment. That is thought to control for environmental factors such as unusual stressors on the 10 O’clock news, any local dramatic weather changes, and so forth.

Interestingly we learned early on in CES work to stay clear of the cross over design in CES studies, after we discovered that the improvement begun by a week or so of CES treatment often continues after treatment is stopped. That is, the patients continue to get better as time goes on following treatment. One can imagine what that does to the statistical analysis when at the end of the study, both groups have improved significantly, but the patients treated first are no longer behaving as good controls should, but are getting even better than the final treatment group is showing. Many otherwise good studies were lost early on due to that effect. It is interesting, for example that the study that obtained by far the worst apparent improvement among the 38 studies was a crossover study.

Safety

It is interesting to note that not one problem from negative side effects has ever been found in any published CES anxiety study. None of the patients has threatened or attempted suicide during or following treatment. None has complained of grogginess the next day. None has complained of headaches or a foggy feeling following treatment. When asked, CES patients have reported instead feeling more rested, more alert, and less tired following treatment.

One interesting clinical detail we learned early on is that patients who have not been sleeping well when they enter a study sometimes make up for lost REM sleep during CES treatment and have the most vivid, most colorful dreams they have ever had. We learned to warn study participants of this in advance, since some earlier patients associated this with incipient schizophrenia or some other serious mental condition. Once alerted to the possibility they have always looked forward to the effect with real anticipation.

References

1. Bianco, F. Jr. (1994) The efficacy of cranial electrotherapy stimulation (CES) for the relief of anxiety and depression among polysubstance abusers in chemical dependency treatment. Ph.D. Dissertation, The University of Tulsa.

2. Gibson, T.H. and D.E. O’Hair (1987) Cranial application of low level transcranial electrotherapy vs. relaxation instruction in anxious patients. American Journal of Electromedicine. 4(1):18-21.

3. Gomez, E. and A.R. Mikhail (1978) Treatment of methadone withdrawal with cerebral electrotherapy (electrosleep). British Journal of Psychiatry. 134:111-113.

4. Hearst, E.D., C.R. Cloninger, E.L. Crews, and R.J. Cadoret (1974) Electrosleep therapy: a double-blind trial.Archives of General Psychiatry. 30(4):463-466.

5. Heffernan, M. (1995) The effect of a single cranial electrotherapy stimulation on multiple stress measures.The Townsend Letter for Doctors and Patients. 147:60-64

6. Heffernan, M. (1996) comparative effects of microcurrent stimulation on EEG spectrum and correlation dimension. Integrative Physiological and Behavioral Science. 31(3):202-209.

7. Jamelka, R. (1975) Cerebral electrotherapy and anxiety reduction. Master’s Thesis, Stephen F. Austin State University.

8. Krupitsky, E.M., A.M. Burakov, G.F. Karandashova, J. Katsnelson, V.P. Lebedev, A.J. Grinenko, and J.S. Borodkin (1991). The administration of transcranial electric treatment for affective disturbances therapy in alcoholic patients. Drug and Alcohol Dependence. 27:1-6.

9. Levitt, E.A., N.M. James, and P. Flavell (1975) A clinical trial of electrosleep therapy with a psychiatric inpatient sample. Australian and New Zealand Journal of Psychiatry. 9(4):287-290.

10. Passini, F.G., C.G. Watson, and J. Herder (1976) The effects of cerebral electric therapy (electrosleep) on anxiety, depression, and hostility in psychiatric patients. Journal of Nervous and Mental Disease. 163(4):263-266.

11. Philip, P. J. Demotes-Mainard, M. Bourgeois, and J.D. Vincent (1991) Efficiency of transcranial electrostimulation on anxiety and insomnia symptoms during a washout period in depressed patients; a double-blind study. Biological Psychiatry 29:451-456.

12. Ryan, J.J. and G.T. Souheaver (1976) Effects of transcerebral electrotherapy (electrosleep) on state anxiety according to suggestibility levels. Biological Psychiatry 11(2):233-237.

13. Ryan, J.J. and G.T. Souheaver (1977) The role of sleep in electrosleep therapy for anxiety. Diseases of the Nervous System. 387):515-517.

14. Sausa, A.D. and P.C. Choudbury (1975) A psychometric evaluation of electrosleep. Indian Journal of Psychiatry. 17:133-127.

15. Schmitt, R., T. Capo, and E. Boyd (1986) Cranial electrotherapy stimulation as a treatment for anxiety in chemically dependent persons. Alcoholism: Clinical and Experimental Research. 10(2):158-160.

16. Smith, R.B., A. Tiberi, and J. Marshall (1994). The use of cranial electrotherapy stimulation in the treatment of closed-head-injured patients. Brain Injury. 8(4):357-361.

17. Taylor, D.N. (1991) Effects of cranial transcutaneous electrical nerve stimulation in normal subjects at rest and during stress. PhD Dissertation, Brooklyn College of the City University of New York.

18. Voris, M.D. (1995) An investigation of the effectiveness of cranial electrotherapy stimulation in the treatment of anxiety disorders among outpatient psychiatric patients, impulse control parolees and pedophiles.Dallas:Delos Mind/Body Institute, pp 1-19.

19. Weingarten, E. (1981) The effect of cerebral electrostimulation on the frontalis electromyogram. Biological Psychiatry 16(1):61-63.

20. Winick, R.L. (1999) Cranial electrotherapy stimulation (CES): A safe and effective low cost means of anxiety control in a dental practice. General Dentistry. 47(1):50-55.

21.Rosenthal, S.H. (1972) Electrosleep; a double-blind clinical study. Biological Psychiatry 4(2):179-185.

22. Smith, R.B. and L. O’Neill (1975) Electrosleep in the management of alcoholism. Biological Psychiatry.10(6):675-680

23. Feighner, J.P., S.L. Brown, and J.E. Olivier (1973) Electrosleep therapy: A controlled double-blind study.Journal of Nervous and Mental Disease. 157(2):121-128.

24. Frankel, B.L., R. Buchbinder, and F., Snyder (1973) Ineffectiveness of electrosleep in chronic primary insomnia. Archives of General Psychiatry. 29:563-568.

25. Moore, J.A., C.S. Mellor, K.F. Standage, and H.A. Strong (1975) A double-blind study of electrosleep for anxiety and insomnia. Biological Psychiatry. 10(1):59-63.

26. Von Richthofen, C.L. and C.S. Mellor (1980) Electrosleep therapy: a controlled study of its effects in anxiety neurosis. Canadian Journal of Psychiatry. 25(3):213-229.

27. Flemenbaum, A. (1974) Cerebral electrotherapy (e1ectrosleep): an open clinical study with a six month follow-up. Psychosomatics. 15(1):20-24.

28. McKenzie, R.E., S..H. Rosenthal, and J.S. Driessner, (1976) Some psycho-physiologic effects of electrical transcranial stimulation (electrosleep). In Wulfsohn, N.L. and Sances, A. (Eds) The Nervous System and Electric Currents. (New York: Plenum) pp 163-167.

29. Magora, F., A. Beller, M.I. Assael, and A. Askeknazi (1967) Some aspects of electrical sleep and its therapeutic value, in Wageneder, F.M. and St. Schuy (Eds.) Electrotherapeutic Sleep and Electroanaesthesia.(Amsterdam: Excerpta Medica Foundation) International Congress Serious Noi. 136. pp. 129-135.

30. Matteson, M.T., and J.M. Ivancevich (1986) An exploratory investigation of CES as an employee stress management technique. Journal of Health and Human Resource Administration. 9:93-109.

31.Overcash, S.J. (1999) A retrospective study to determine the efficacy of cranial electrotherapy stimulation (CES) on patients suffering from anxiety disorders. American Journal of Electromedicine 16(1):49-51.

32. Overcash, S.J. and A. Siebenthall (1989) The effects of cranial electrotherapy stimulation and multisensory cognitive therapy on the personality and anxiety levels of substance abuse patients. American Journal of Electromedicine. 6(2):105-111.

33. Patterson, M.A., J. Firth, and R. Gardiner (1984) Treatment of drug, alcohol and nicotine addiction by neuroelectric therapy: analysis of results over 7 years. Journal of Bioelectricity. 3(1&2):193-221.

34. Rosenthal, S.H., and N.L. Wulfson (1970) Electrosleep: A clinical trial. American Journal of Psychiatry127(4):175-176.

35. Rosenthal, S.H., and N.L. Wulfson (1970) Electrosleep: A clinical trial. American Journal of Psychiatry127(4):175-176.

36. Smith, R.B. (1999) Cranial electrotherapy stimulation in the treatment of stress related cognitive dysfunction, with an eighteen month follow up. Journal of Cognitive Rehabilitation 17(6):14-18.

37. Smith, R.B. and F.N. Shiromoto (1992) The use of cranial electrotherapy stimulation to block fear perception in phobic patients. Current Therapeutic Research. 51(2):249-253.

38. Voris, M.S. and S. Good (1996) Treating sexual offenders using cranial electrotherapy stimulation. Medical Scope Monthly. 3(11):14-18.

A Summary Look at CES Studies of Cognitive Function

By Ray B. Smith, Ph. D.

Executive Summary. Thirteen studies, in which a total of 648 patients with various types of cognitive dysfunction were treated with cranial electrotherapy stimulation (CES), were combined statistically in order to get a more confident look at the effectiveness of CES for treating this condition. While many of the studies were of the classic double blind protocol, others used either the single blind or open clinical trial. The result of the analysis showed that the overall effectiveness of CES was 44% improvement. When the 7 studies of patients with substance abuse and the 3 studies of fibromyalgia patients were analyzed separately it was found that the substance abuse patients averaged a 60% improvement, while the fibromyalgia patients gained a modest but significant 17%. The results indicate that a different etiology is most likely driving the cognitive dysfunction in the two. Perhaps in one group a more basic physiological change was at work due to the history of substance abuse, while the fibromyalgia patients may have simply been driven to cognitive distraction by their intractable pain. Elsewhere it was noted that the “permanent brain damage” that was said to be a condition of long term substance abuse patients as late as the 1980s, has now been seen to return to within normal functional limits following 3 weeks of daily CES treatment.

Introduction

The goal of clinical studies is always to first test the effectiveness of a potential treatment and secondly to discover which patients the treatment may be most effective in treating. Meta-analysis has the effect of allowing us to essentially study a larger number of patients than can usually be assembled for a single study, and the larger the combined study sample, the greater is the confidence that can be placed in the study outcome: that the study findings are true and accurate. Also, the more diverse the study group is in the combined sample, the more confident can we be in generalizing the study outcome to larger groups of people outside the study. That is, it increases the range of potential types of cognitive dysfunction patients that we can predict will be effectively treated with CES.

In the table below is a summary of 13 studies that were combined into the meta-analysis reported on here.

Studies of Cognitive Function Completed Over the Past 31 Years

Study Design

Zr Score^a

Presenting

Group

No. Subjects

Measure Used^b

Reference

Double Blind

.1.020

Substance

Abuse

Profile Of Mood States

Double Blind

.829

Substance

Abuse

Psychological Tests

Double Blind

.151

Fibromyalgia

Profile of Mood States

Totals

2.000

180

Average

.667

Effect Size^c

r = .58

Single Blind

.604

Substance

Abuse

Profile of Mood States

Single Blind

1.293

Substance

Abuse

227

Psychological

Tests

Single Blind

..388

Substance

Abuse

Profile of Mood States

Single Blind

.234

Substance

Abuse

100

Psychological Test

Totals

2.519

423

Average

.630

Effect Size

r =.56

Open Clinical

.172

Graduate Students

Profile of Mood States

Open Clinical

.412

Post Traumatic Syndrome

Neuropsychiatric Texts

Open Clinical

.497

Substance

Abuse

EEG

Open Clinical

.203

ADHD

Psychological Tests

Open Clinical

..182

Fibromyalgia

Profile of Mood States

Open Clinical

.182

Fibromyalgia

Profile of Mood States

Totals

1.648

299

Average

.275

Effect Size

r =.27

SUMMARY, ALL COGNITION STUDIES REPORTED ABOVE

Grand Total

6.167

648

Average

.474

Total Effect Size

r =.44

SUMMARY OF SUBSTANCE ABUSE PATIENTS ONLY

Totals

4.865

558

Average

.695

Effect Size

.60

SUMMARY OF FIBROMYALGIA PATIENTS ONLY

Totals

.515

140

Average

.172

Effect Size

.17

^a Since percent improvement scores can not legally be averaged, they are converted into Zr scores, averaged, and then converted back to percent improvement (effect size.)

^b The Profile of Mood States is of published reliability and validity, as were each of the psychological tests used in the above studies.

^c Effect size, here, is a statistician’s basic estimate of the overall percentage improvement by the patients as a result of the treatment

Discussion

In most of the studies, cognitive confusion was but one symptom within a larger syndrome. For example, in most of the studies, substance abuse was the presenting syndrome, while in three of the 13 studies, fibromyalgia was the presenting syndrome. And while all presented symptoms of cognitive confusion of some type, it is obvious from the above secondary analysis, that the cognitive dysfunction among the substance abuse patients was very likely of a different, physiological etiology than that of the fibromyalgia patients, who may have been experiencing cognitive distraction due to the stress of the unrelenting pain of their condition.

A word about the study types. In the open clinical study, the patients know they are being actively treated for their level of cognitive functioning, the clinicians know who is being treated, and the statistician who summarizes the study data also knows, since there is only one group of patients.

Interestingly, in a good double blind experimental design, such as was the case in the majority of those reported in the table, the persons who were responsible for measuring or rating patient improvement were also blind as to whom was treated, as was the statistician who was given anonymous groups of data to analyze. Note that, in effect, that makes such studies quadruple blind, but that term is not used in science.

Safety

It is interesting to note that not one problem from negative side effects has ever been reported in any published CES study. None of the patients has raided the fridge during the night and gained weight. None has complained of grogginess the next day. None has complained of headaches or a foggy feeling following treatment. Nor has CES been associated with increased suicide rates. When asked, CES patients have reported instead feeling more rested, more alert, and less tired following treatment.

References

1. Schmitt, R., T. Capo, H. Frazier, and D. Boren (1984) Cranial electrotherapy stimulation treatment of cognitive brain dysfunction in chemical dependence. Journal of Clinical Psychiatry. 45:60-063.

2. Schmitt, R., T. Capo, and E. Boyd (1986) Cranial electrotherapy stimulation as a treatment for anxiety in chemically dependent persons. Alcoholism: Clinical and Experimental Research. 10(2):158-160.

3. Lichtbroun, A.S., M.C. Raicer, and R.B. Smith (2001) The treatment of fibromyalgia with cranial electrotherapy stimulation. Journal of Clinical Rheumatology. 7(2):72-78.

4. Smith, R.B. and L. O’Neill (1975) Electrosleep in the management of alcoholism. Biological Psychiatry. 10:765-680.

5. Smith, R.B., and E. Day (1977) The effects of cerebral electrotherapy on short-term memory impairment in alcoholic patients. International Journal of the Addictions, 12:575-562.

6. Weingarten, E. (1981) The effect of cerebral electrostimulation on the frontalis electromyogram. Biological Psychiatry. 16(1):61-63.

7. Smith, R.B. (1982) Confirming evidence of an effective treatment for brain dysfunction in alcoholic patients.Journal of Nervous and Mental Disease. 170:275-278.

8. Matteson, M.T., and J.M. Ivancevich (1986) An exploratory investigation of CES as an employee stress management technique. Journal of Health and Human Resource Administration. 9:93-109.

9. Childs, A., and M.L. Crismon (1988) The use of cranial electrotherapy stimulation in post-traumatic amnesia: a report of two cases. Brain Injury. 2:243-247.

10. Braverman, E., R.B. Smith, R. Smayda and K. Blum (1990) Modification of P300 amplitude and other electrophysiological parameters of drug abuse by cranial electrical stimulation. Current Therapeutic Research.48(4):586-596.

11. Smith, R.B. (1999) Cranial electrotherapy stimulation in the treatment of stress related cognitive dysfunction, with an eighteen month follow up. Journal of Cognitive Rehabilitation 17(6):14-18.

12. Tyers. S., and R.B. Smith (2001) A comparison of cranial electrotherapy stimulation alone or with chiropractic therapies in the treatment of fibromyalgia. The American Chiropractor. 23(2):39-41.

13. Tyers, S. and R.B. Smith (2001) Treatment of fibromyalgia with cranial electrotherapy

A Summary Look at CES Studies Of Depression

By Ray B. Smith, Ph.D.

Executive Summary. Eighteen studies were analyzed, in which a total of 853 patients were treated with cranial electrotherapy stimulation (CES) for depression. The patients had presented with various clinical syndromes, of which depression played a major part. The treatment outcome depression scores were combined statistically in order to get a more confident look at the effectiveness of CES for treating this condition. While many of the studies were of the classic double blind protocol, others used either the single blind, the cross over design or were open clinical trials. The result of the analysis showed that the overall effectiveness of CES was 47% improvement. The results indicated that various types of depression, which accompany a wide range of clinical syndromes can be expected to respond, sometimes dramatically to CES treatment.

Introduction

The goal of clinical studies is always to first test the effectiveness of a potential treatment and secondly to discover which patients the treatment may be most effective in treating. Meta-analysis has the effect of allowing us to essentially study a larger number of patients than can usually be assembled for a single study, and the larger the combined study sample, the greater is the confidence that can be placed in the study outcome: that the study findings are true and accurate. Also, the more diverse the study group is in the combined sample, the more confident one can be in generalizing the study outcome to larger groups of patients outside the study. That is, it increases the range of potential types of depression patients that we can predict will be effectively treated with CES.

In the table below is a summary of 18 studies that were combined into the meta-analysis reported on here.

CES Depression Studies Completed Over the Past 36 Years

Study Design

Zr Score^a

Presenting

Group

No. Subjects

Measure Used^b

Reference

Double Blind

1.099

Substance

Abuse

Clinical Rating Scales

Double Blind

.283

Substance

Abuse

Self Rating Scale

Double Blind

.255

Psychiatric

Inpatients

Clinical Rating

Scale

Double Blind

.310

Closed Head Injured

Self Rating Scale

Double Blind

.321

Fibromyalgia

Self Rating Scale

Double Blind

.511

Psychiatric

Outpatients

Clinician’s Rating

Double Blind

.900

Insomnia,

Anxiety

Clinician’s Rating

Totals

3.679

176

Average

.526

Effect Size^c

r = .48

Single Blind

.486

Psychiatric

Outpatients

Clinical Rating Scales

Single Blind

.881

Substance

Abuse

Self Rating Scale

Totals

1.367

Average

.684

Effect Size

r =.60

Crossover

.219

Psychiatric

Inpatients

Clinician’s Rating

Crossover

.929

Insomnia, Depression

Self Rating Scale

Totals

1.148

Average

.574

Effect Size

r =.52

Open Clinical

.354

Graduate

Students

Self Rating Scale

Open Clinical

.365

Fibromyalgia

Self Rating Scale

Open Clinical

.266

Fibromyalgia

Self Rating Scale

Open Clinical

.662

Pain,

Depression

318

Self Rating

Open Clinical

.350

Psychiatric

Outpatients

Clinical Rating Scale

Open Clinical

.549

Chronic Pain, Depression

Serum Analysis

Open Clinical

.332

ADHD

Self Rating Scale

Totals

2.878

532

Average

.411

Effect Size

r =.39

SUMMARY, ALL DEPRESSION STUDIES REPORTED ABOVE

Grand Total

9.072

853

Average

.504

Total Effect Size

r =.47

^a r correlation scores, representing percent improvement, are obtained mathematically from the study outcomes presented by the authors. Scores such as percent change scores, the statistical probability scores reported, Fscores, t scores, and the like, are changed to r correlation scores and then into Zr scores. That is because percent improvement scores can not legally be averaged. The Zr scores are then averaged and converted back to percent improvement (effect size.)

^b Most of the rating scales, both by the patients and the clinicians were of published reliability and validity. In many of the studies, more than one measure of depression was used. In those cases, the average of the results was calculated and reported as the overall result of the study.

^c Effect size, here, is a statistician’s basic estimate of the overall percentage improvement by the patients as a result of the treatment

Discussion

In many of the studies, depression was but one symptom within a larger presenting syndrome. For example in many of the patients, fibromyalgia was the presenting symptom, while in another large group of studies substance abuse (drug abstinence syndrome) was the presenting diagnosis. The presenting syndrome or type of patient is given in column three of the table. In all of the studies, however, depression was a major diagnosis within the presenting syndrome or group.

A word about the study types. In the open clinical study, the patients know they are being actively treated for their depression, the clinicians know who is being treated, and the statistician who summarizes the study data also knows, since there is only one group of patients.

Interestingly, in a good double blind experimental design, such as was the case in the majority of those reported in the table, the persons who were responsible for measuring or rating patient improvement were also blind as to whom was treated, as was the statistician who was given anonymous groups of data to analyze. Note that, in effect, that makes such studies quadruple blind, but that term is not used in science.

In the crossover design, half the patients get treated the first week or two of the study, while the other half receive sham treatment. In the second half of the study, the formerly treated patients now receive sham treatment while the formerly sham treated patients now receive treatment. If the crossover does not involve a sham treatment condition, then the crossover study is treated as an open clinical trial where all patients and staff know who is being treated at each cross of the study. That design is often referred to as a study with “wait in line” controls, in that the patients waiting to begin treatment are tested before and at the end of the waiting period before going into treatment. That is thought to control for environmental factors such as unusual stressors on the 10 O’clock news, any local dramatic weather changes, and so forth.

Interestingly we learned early on in CES work to stay clear of the cross over design in CES studies, after we discovered that the improvement begun by a week or so of CES treatment often continued after the end of treatment. That is, the patients continue to get better as time goes on following treatment. One can imagine what that does to the statistical analysis when at the end of the study, both groups have improved significantly, but the patients treated first are no longer behaving as good controls should, but are getting even better than the final treatment group is showing. Many otherwise good studies were lost early on due to that effect. The two crossover studies reported in the table above obviously avoided this difficulty, perhaps due to shorter term treatment before the crossover.

Safety

It is interesting to note that not one problem from negative side effects has ever been reported in any published CES depression study. None of the patients has threatened or attempted suicide during or following treatment. None has complained of grogginess the next day. None has complained of headaches or a foggy feeling at the end of the treatment period. When asked, CES patients have reported instead feeling more rested, more alert, and less tired following treatment.

References

2. Krupitsky, E.M., A.M. Burakov, G.F. Karandashova, J. Katsnelson, V.P. Lebedev, A.J. Grinenko, and J.S. Borodkin (1991). The administration of transcranial electric treatment for affective disturbances therapy in alcoholic patients. Drug and Alcohol Dependence. 27:1-6.

3. Levitt, E.A., N.M. James, and P. Flavell (1975) A clinical trial of electrosleep therapy with a psychiatric inpatient sample. Australian and New Zealand Journal of Psychiatry. 9(4):287-290.

4. Smith, R.B., A. Tiberi, and J. Marshall (1994). The use of cranial electrotherapy stimulation in the treatment of closed-head-injured patients. Brain Injury. 8(4):357-361.

5. Lichtbroun, A.S., M.C. Raicer, and R.B. Smith (2001) The treatment of fibromyalgia with cranial electrotherapy stimulation. Journal of Clinical Rheumatology. 7(2):72-78.

6. Rosenthal, S.H. (1972) Electrosleep: A double-blind clinical study. Biological Psychiatry. 4(2):179-185.

7. Moore, J.A., C.S. Mellor, K.F. Standage, and H.A. Strong (1975) A double-blind study of electrosleep for anxiety and insomnia. Biological Psychiatry. 10(1):59-63.

8. Rosenthal, S.H., and N.L. Wulfson (1970) Electrosleep: A clinical trial. American Journal of Psychiatry127(4):175-176.

9. Smith, R.B. and L. O’Neill (1975) Electrosleep in the management of alcoholism. Biological Psychiatry.10(6):675-680.

10. Feighner, J.P., S.L. Brown, and J.E. Olivier (1973) Electrosleep therapy: A controlled double-blind study.Journal of Nervous and Mental Disease. 157(2):121-128.

11. Hearst. E.D., C.R. Cloninger, E.L. Crews, and R.J. Cadoret (1974) Electrosleep therapy: a double-blind trial.Archives of General Psychiatry. 30(4):463-466.

12. Matteson, M.T., and J.M. Ivancevich (1986) An exploratory investigation of CES as an employee stress management technique. Journal of Health and Human Resource Administration. 9:93-109.

13. Tyers. S., and R.B. Smith (2001) A comparison of cranial electrotherapy stimulation alone or with chiropractic therapies in the treatment of fibromyalgia. The American Chiropractor. 23(2):39-41.

14. Tyers, S. and R.B. Smith (2001) Treatment of fibromyalgia with cranial electrotherapy stimulation. The Original Internist 8(3):15-17.

15. Smith, R.B. (2001) Is microcurrent stimulation effective in pain management? An additional perspective.American Journal of Pain Management. 11(2):62-66.

16. Rosenthal, S.H., and N.L. Wulfson (1970) Electrosleep: A clinical trial. American Journal of Psychiatry127(4):175-176.

17. Shealy, C.N., R.K. Cady, R.G. Wilkie, R. Cox, S. Liss, and W. Clossen (1989) Depression: a diagnostic, neurochemical profile and therapy with cranial electrical stimulation (CES). Journal of Neurological and Orthopaedic Medicine and Surgery. 10(4):319-321.

18. Smith R.B. (1999) Cranial electrotherapy stimulation in the treatment of stress related cognitive dysfunction, with an eighteen month follow up Journal of Cognitive rehabilitation.

Cranial Electrotherapy Stimulation

Possible Mechanisms of Action

By Ray B. Smith, Ph.D.

Any time a new medical treatment comes on line, there is pressure to explain how it works. While Cranial Electrotherapy Stimulation (CES) has been in medical use for the past 53 years (it came into being as “electrosleep” in Europe in 1953), there has been no definitive, settled explanation of its mechanism of action.

To explain its mechanism satisfactorily, a treatment has to be understood within one of the accepted explanatory concepts currently in vogue in medical science. Some of the theories that are more or less active at present are as follows:

The Nervous System. The major current concept is that the body functions via a more or less hard wired nervous system. In this theoretical system, the body is neuronally wired to receive incoming stimuli via its afferent neurons, send them to the central nervous system, which then sends out response stimuli via its efferent neurons. One touches a finger accidentally to a hot surface and the finger is immediately jerked away from the hot stove, for example.

Since the neurons don’t ordinarily physically touch, the neural wiring functions via synaptic endings on the neurons in which the pre synaptic membrane discharges neurochemicals from stored vesicles into the synapse between the neurons and these stimulate receptors on the post synaptic membrane (the receiving membrane of the neuron next in line to fire) and that neuron fires the next neuron or the sensitive membrane on a muscle receptor, and so forth.

To work as efficiently as it was designed to work, all the neurons must be intact, and all the neurochemicals that are involved in the neurological firing patterns have to be in balance with all the others. If one neurochemical is out of balance, either it over fires or under fires the system for which it is responsible, in which case physical or emotional symptoms of one kind or another arise. For example, if there is not enough dopamine, Parkinson like symptoms develop. If there is not enough serotonin, depression results, etc.

If CES is to be effective within this system, then it must be shown that CES acts to bring back into balance neurotransmitters that are out of balance with their associates. Pozos completed a series of interesting experiments with canine subjects that looked at this possibility. They examined the adrenergic-cholinergic balance in the brain.

His research group theorized that if CES actually stimulated neurons to fire, as CES salesmen were claiming, he could give some of the dogs reserpine plus CES stimulation and the reserpine would block the reuptake of dopamine into the presynaptic vesicles. That would reduce the amount of dopamine available in the presynaptic vesicles to fire the postsynaptic neurons on the adrenergic side, and the cholinergic system would gain the upper hand. He did that, and discovered that in doing so he had thrown the adrenergic system out of balance with the cholinergic system and the dogs began to show Parkinson like symptoms.

Pozos was not directly measuring dopamine in the dog’s brain, however, so he thought he would do some more experiments to make sure he was in the right ballpark. He decided to block the uptake of acetylcholine on the other side of the adrenergic-cholinergic equation. It was the acetylcholine uptake that was firing that side of the equation and instigating the Parkinson like symptoms. To do this, he gave his CES stimulated dogs, which were still in Parkinson like tremors, some atropine to block the acetylcholine uptake. The tremors ceased.

He decided that since he was not, after all, measuring either dopamine or acetylcholine, he would check the system further by taking another group of CES treated, tremoring dogs, remove the atropine from the cholinergic side and add physostigmine instead. Physostigmine would actually stimulate the cholinergic nerves to fire more rapidly than usual. He did this, and the dogs showed the most pronounced tremors ever.

Pozos was reasonably certain that he had the correct system and had shown that CES could effectively stimulate an increase in the manufacture of dopamine. But wait. If that were the case, then CES should be able to put the terribly out of balance system in the dog’s brain back to normal when all provoking chemicals were removed. To that end, he removed the drugs from all the dogs’ systems, gave all of them regular food and water for the following week. In addition, a third received L-Dopa, and another third of them received CES stimulation.

The non treated animals returned to normal, non-Parkinson like states within three to five days. The CES treated animals, however, returned to normal, non-Parkinson like states within 3 to 7 hours, as did the third of the animals receiving L-Dopa.¹

Another study actually counted the number of presynaptic vesicles in presynaptic membranes of squirrel monkeys before, after several minutes of CES stimulation, and for a time following the cessation of stimulation. Their findings convinced them that CES acted essentially to stimulate the vesicles to empty their contents, thus reducing them in number. But CES then acted to dramatically increase the number of new vesicles formed as stimulation continued. Once the stimulation had ceased, the number of vesicles tended to gradually return to their pre stimulus levels over time.²

A similar study was run in human narcotics addicts in which the depletion of endorphin by the narcotics had presumably thrown off the balance between the endorphin and norepinephrine systems in the locus ceruleus of the brain. Once the narcotics, which had been mimicking endorphin and thereby down-regulated that system, were removed, norepinephrine got the upper hand and physiological withdrawal symptoms began. The researchers knew that they could block the post synaptic receptors to norepinephrine with alpha methyl dopa and thereby stop the withdraw symptoms, but thought they would also try CES stimulation on half of the patients to see if CES could stimulate increased endorphin production, and thereby rebalance the system.

They found that both treatments worked equally well, so that the physicians who monitored the double blind research could never tell which patients were treated with alpha methyl dopa and which were receiving CES. Until after the study, that is, when the drug patients went into rebound depression and the CES treated patients did not.³

Acupuncture theories. Following President Nixon’s visit to China, acupuncture treatment came into a sort of vogue in the U.S. and still plays a role in some medical circles. The theory behind acupuncture is that the body works on an energy homeostasis and at times, and for any number of reasons that system can be thrown out of balance. It was for that reason that earlier on CES was thought by many to perhaps have its effects by stimulating this system to increased energy balance when insufficient energy was present in the system to keep the body working normally.

Energy is known to flow through the collagen connective tissues of the body, and some areas of the body are more sensitive to energy incoming in to that system than others. These sensitive areas are known as acupuncture points, and CES may well supply energy to that system, though not necessarily by stimulating those points directly.

CES electrodes are placed at various places on the head so that the stimulating current is allowed to pass through the head. CES current has been shown to spread around the head and scalp while also going through the entire brain, though canalizing along the limbic, or “emotion” brain.⁴

As anyone knows who has placed CES electrodes on the mastoid processes behind the ears and turned the current up, one tends to get an involuntary grin when the current spreads to the facial muscles, and similarly, there can be light flashes keeping time with the CES pulse as the energy passes through the ocular apparatus in the eyes. For this reason, it is very likely that any acupuncture points on or about the head would receive sufficient stimulation, wherever they are located, to respond to CES stimulation. For example, in some therapeutic strategies, several of those points on the face are said to be dramatically activated by merely softly tapping on them with the finger tips.⁵Not enough is known about the acupuncture system by the present author to speculate further on just how CES may effect bodily changes via the acupuncture route, but it may be shown to do so in the future..

There are other energy flow systems that are active throughout the body, such as the vascular system as an electrical transmission system. Nordenstrom has shown that the vascular system acts as a biologically closed electric circuit in which energy flows readily, pulling and pushing electrically charged blood components so as to keep the body in functional homeostasis. That system is active both in the arteries and veins, whose walls act as insulation, and in the vascular-interstitial spaces.⁶ To date, no known studies of how CES effects or interacts with this system exists.

Nor are any CES studies known to exist regarding the perineural electrical system which Becker has shown also acts throughout the body as an electrical system acting peripherally to, but separately from the nervous system.⁷

EEG studies. Numerous EEG studies, MRI studies and the like have been done with CES stimulated subjects, several of which are reported in the sleep studies and addiction studies sections. Several of those studies are ongoing, and new ones are being planned as this is being written. In looking through the various studies that have been done over the years, it can be stated that CES is invariably found to work changes in the brain’s neural firing pattern. While the effects of those changes can be difficult to decipher, none has been thought to have a negative impact of any sort on the patients studied. For example, no seizures have ever been detected accompanying CES treatment, even among known seizure patients.⁸

Neurohormonal studies. Several studies have been done on the ability of CES to effect a return to more normal conditions hormones that are out of balance in depressed patients,⁹ and those such as DHEA, testosterone, estrogen, and IGF-1 in older subjects in whom those hormone levels were low.¹⁰

Synchronicity Theory. The science of spontaneous order as the synchronicity field is now being called appears to be rising fast as a new way of describing medically related phenomena.¹¹ In this theory, every part of the body is seen to be functionally synchronized with every other part, and each organ is specifically functionally synchronized within itself. The entire body is also synchronized with the external environment. When any part of the body becomes desynchronized on any of the three synchronicity levels illness results.

Synchronicity can easily be seen on TV nature channels when thousands of schooling fish dart first in one direction and then another, quite spontaneously and never hitting another nearby fish when attacked by a feeding shark. Large flocks of migrating birds can be seen wheeling at high speeds overhead in first one direction and then another without ever colliding even though there may be hundreds of birds flying in the close formation.

Similarly, in the human body, all liver cells have to be functioning in sync for the liver to get its work done. The same is true of the pancreas, the heart muscles, the adrenal glands, and so forth. Further all the various organs, even while entraining their separate rhythms, have to work in synchrony with all the others if the body is to function properly.¹²

The master clock that regulates circadian rhythm in the rat has been found to be a monosynaptic neural pathway from the retina in the eye to the two small suprachiasmatic nuclei in front of the hypothalamus. This pathway, while originating in the eye, has nothing to do with vision, nor does it fire into any visual centers of the brain. It appears to be dedicated specifically to the purpose of regulating the synchronicity between the rat and its external environment.

Researchers are still looking for the master clock within each of our body’s organs and in the body as a whole. The future may well show that the incoming, timed rhythmic pulsations of electric energy involved in CES treatment acts in some way to reset a desynchronized body back into normal synchronicity and thereby produces a more healthful functioning.

Summary

CES has been shown to travel throughout the brain, and in the process bring back to normal neurohormonal systems that have been deliberately thrown out of balance by researchers or by patients themselves, in the case of narcotics addicts. It has been shown to bring back to more youthful levels several hormones that are typically reduced in aging.

CES, then, is thought to act to balance physiological systems that have become unbalanced by whatever means. An interesting corollary to that is the often obtained clinical finding that once a patient is back in balance – these are often seen in the drug abstinence syndrome, for example – CES ceases to have an effect and the patient stops using it. For that reason it is known to not be addicting or habit forming in any way. And in none of the studies to date has a significant negative side effect been reported.

References

1. Pozos, R.S., L.E. Strack, R.K. White, and A.W. Richardson (1971) Electrosleep versus electroconvulsive therapy. In Reynolds, D.V. and A.E. Sjorberg, (Eds) Neuroelectric Research. Springfield, Charles Thomas. pp 221-225.

2. Siegesmund, K.A., A. Sances Jr., and S.J. Larson (1967) The effects of electrical currents on synaptic vesicles in monkey cortex. In Wageneder, F.M. and St. Shuy (Eds) Electrotherapeutic Sleep and Electroanaesthesia. International Congress Series No. 136. Neew York: Excerpta Medica Foundation, kpp 31-33.

3. Gold, M.S., A.L.C. Pottash, H. Sternbach, J. Barbaban, and W. Annitto (1982) Anti-withdrawal Effects of Alpha Methyl Dopa and Cranial Electrotherapy. Paper presented at The Society for Neuroscience. 12^th Annual Meeting, October.

4. Jarzembski, W.B., S.J. Larson, and A. Sances Jr. (1970) Evaluation of specific cerebral impedance and cerebral current density. Annals of the New York Academy of Sciences, 170:476-490.

5. Flint, G.A. (2001) Emotional Freedom; Techniques for Dealing with Emotional and Physical Distress.Vernon, British Columbia: NeoSolterric Enterprises. pp 25-26.

6. Nordenstrom, B.E.W. (1983) Biologically Closed Electric Circuits; Clinical, Experimental and Theoretical Evidence for an Additional Circulatory System. Stockholm:Nordic Medical Publications. pp 269-317.

7. Becker, R.O., and G. Selden (1985) The Body Electric; Electromagnetism and the Foundation of Life. New York: Williami Morrow. pp 79-117.

8. Smith, R.B., A. Tiberi, and J. Marshall (1994). The use of cranial electrotherapy stimulation in the treatment of closed-head-injured patients. Brain Injury. 8(4):357-361.

9. Shealy, C.N., R.K. Cady, R.G. Wilkie, R. Cox, S. Liss, and W. Clossen (1989) Depression: a diagnostic, neurochemical profile and therapy with cranial electrical stimulation (CES). Journal of Neurological and Orthopaedic Medicine and Surgery. 10(4):319-321.

10. Smith, R.B. and C.A. Ryser (2000) Important Things we Learn When Research Goes Awry. Paper presented at the International Oxidative Medicine Association conference, Denver, Colorado.

11. Strogatz, S. (2003) Sync; the Emerging Science of Spontaneous Order. New York: Hyperion books. pp 70-100.

A Summary Look at CES Sleep Studies

Ray B. Smith, PhD

Executive Summary. Eighteen studies, in which a total of 648 patients with various types of sleep disorders were treated with cranial electrotherapy stimulation (CES), were combined statistically in order to get a more confident look at the effectiveness of CES for treating this condition. While most of the studies were of the classic double blind protocol, others used either the single blind, the cross over design or were open clinical trials. The result of the analysis showed that the overall effectiveness of CES was an impressive 62% improvement, and when the studies were weighted in terms of the rigorousness of the study design employed, the improvement was found to be an even stronger 67%. The results also indicated that a wide range of sleep disorders can be expected to respond to CES treatment.

Introduction

The goal of clinical studies is always to first test the effectiveness of a potential treatment and secondly to discover which patients the treatment may be most effective in treating. Meta-analysis has the effect of allowing us to essentially study a larger number of patients than can usually be assembled for a single study, and the larger the combined study sample, the greater is the confidence that can be placed in the study outcome: that the study findings are true and accurate. Also, the more diverse the study group is in the combined sample, the more confident can we be in generalizing the study outcome to larger groups of people outside the study. That is, it increases the range of potential types of insomnia patients that we can predict will be effectively treated with CES.

In the table below is a summary of 18 studies that were combined into the meta-analysis reported on here.

CES Sleep Studies Completed Over the Past 43 Years

Study Design

Zr Score^a

No. Subjects

Measure Used^b

Reference

Double Blind

.388

EEG, Clinician’s Rating

Double Blind

.908

Self Rating Scale

Double Blind

.875

Self Rating Scale

Double Blind

.590

Clinician’s Rating

Double Blind

.448

Self Rating Scale

Double Blind

1.127

Clinician’s Rating

Double Blind

1.528

EEG, Self Rating Scale

Totals

5.864

188

Average

.838

Effect Size^c

r = .69

Single Blind

1.650

PRN Sleep Meds

Single Blind

.448

Clinician’s Rating