Following the initial research in the U.S., several units began to be sold for clinical use before the 1976 Amendment gave the FDA control over medical devices. The Amendment gave the FDA power to determine the safety and effectiveness of medical devices prior to allowing them into the U.S. marketplace, and all electrosleep devices which were on the open market prior to the Amendment were grandfathered and left on the market, with a provision that the FDA could call them in later to have them show their safety and effectiveness, a process costing up to an estimated $800 million.

The FDA also decided to call electrosleep devices Cranial Electrotherapy Stimulation devices, since by then their clinical uses had expanded from sleep to include depression and anxiety. A preliminary look at CES by the FDA’s Neurology Panel in 1978 suggested they should be accepted for the safe and effective treatment of addictions, and that the other treatment claims should be looked at again as more research became available.

When one looks back at specific neurotransmitter systems that are influenced and possibly rebalanced by CES one finds himself confronted directly with the body’s neurohormonal stress system.

Stress is caused by a person entering a dangerous fight-or-flight situation, and is relieved when the person is no longer in that situation. To operate effectively in such a situation, the body has to dramatically shift its neurohormonal balance out of its normal homeostasis. Stress, in that situation, is very healthy and can even be life saving, such as when a person runs out of the path of an automobile that is swerving toward him out of control, or jumps away from a snake, poised to strike, suddenly encountered on a trail in the woods.

Chronic stress, however, is a different matter and occurs when a person is living in a threatening situation he can not escape… a job, an unfortunate relationship, driving daily in dangerous commuter traffic, watching the evening news on T.V., with every “Oh, my god,” story the news producer can find to put on (“if it bleeds, it leads”14). When under chronic stress, the body’s neurohormonal system does not come back into its normal homeostatic balance, and the resulting imbalance is said to cause up to 90% of the physical illnesses brought to the attention of physicians.

Major symptoms of a system under chronic stress number among them, insomnia, depression, anxiety, posttraumatic stress disorder, various compulsive behavior disorders, not the least of which are the various addictions in which the person uses various drugs (or medications) in an effort to alter the neurohormonal system back to a more acceptable level. Physical problems also increase, such as heart attacks, strokes, diabetes, cancer, obesity, and infections such as colds and flue, among any number of others.

And where does CES treatment interface with this syndrome? From the earlier animal and later human research,17 CES can best be described as an adaptogen, in which CES acts to increase the body’s resistance to adverse influences by reestablishing the homeostatic balance between the body’s various neurotransmitters that have been thrown out of balance by chronic stress. In basically rebalancing the physiological system, CES influences a wide range of physical, chemical and biochemical factors that have a normalizing effect on the body. CES, then, acts to alleviate stress, and in the process improve all kinds of conditions that have been generated by that stress.

For example in 18 studies of insomnia, the average improvement was 62%, in a similar number of depression studies, the average improvement was 47%, while in 38 studies of anxiety, the average improvement was 58%. Those were the average improvement scores. In 31 double blind studies of various psychological problems, while the average improvement was found to be 56%, the range of improvement went from a low of 23% to a high of 91%, a treatment effect never seen in pharmaceutical treatment of those types of disorders.

Highly positive treatment effects have also been found in other areas of dysfunction, such as in persons recovering from the effects of addiction, in children and adults suffering from Attention Deficit Disorder, in persons suffering from stress related memory loss, and in patients suffering from headaches and other types of stress related pain syndromes. And more importantly, no significant negative side effect has ever been reported in more than 46 years of CES research and treatment in the U.S

More recently, following the Vietnam War the Post Traumatic Stress Disorder or PTSD is being given much attention. During World Wars I and II, the disorder was known as shell shock and thought to be caused by the immediate stress of battle. The cure, at the time, was to let the men lie quietly in or just outside the medical tent away from the battle area, and rest until their nerves settled down.

Once the syndrome was described, it was discovered that perhaps 25% or more of persons who have never been in the military have experienced PTSD. It has been precipitated by such things as child abuse or other childhood trauma such as emotional abandonment by parents or parental surrogates. In older persons and adults it has been precipitated by serious car accidents, major surgery, rapes, muggings, and in general by any other event in which the person felt helpless during an event he/she perceived as life threatening. Nine times more females than males are now known to experience PTSD, and up to 75% of persons suffering from fibromyalgia have PTSD either currently or in their background.

It is now known that PTSD represents a basic split off of parts of the brain in which the emotional trauma was recorded, so that the waking brain remains unaware of it. The problem is that the part of the brain storing the memory often reactivates during sleep and the event is recalled in very stressful nightmares. Also, during the day, any number of small stimuli that occur can reactivate that section of the brain, and a flashback occurs. Accompanying a nightmare or flashback, the entire sympathetic nervous system is called into play and the resulting stress, both physical and emotional can be overwhelming.

Because so many things can trigger a flashback, the person slowly but surely closes off ever more sections of the day to day experience and activities in order to not provoke an episode. The brain actually becomes phobic of those activities that can act as triggers, and closes them off from its daily activities and awareness. The person, as a result, remains in hyper aroused alert status, with an ever narrower life view and experience. To those looking on, the person become quieter, less sociable, and tends to limit activities in all areas of his/her life more and more.

CES treatment in PTSD should have a pronounced effect in that PTSD symptoms always increase when the person is under stress of any other kind. Also, the research with CES in phobic patients indicates that phobic fear can not be experienced while CES treatment is in progress, and at least for a time thereafter.21 It is the panic felt by patients when the phobic areas are roused, with the accompanying uncontrolled system wide sympathetic physiological arousal that gives them their greatest fear and dread. To have CES available during those times of panic should be very helpful immediately, and contribute markedly to a longer term cure as those feelings of helplessness dissipate via its use. Also, researchers are warned not to encourage the patient to call up the traumatic event(s) until they have a ready brake or safe spot they can go to if the emotion gets too high and might go out of control otherwise.22 CES might well act as a brake that the patient could use if he could not readily break off the traumatic imagery and get to his safe spot mentally.

For this reason, it has been suggested that the use of CES during desensitization therapy such as Prolonged Exposure Therapy (PET), a therapy found very effective in treating PTSD, should allow desensitization therapy proceed at a much more rapid rate, and possible be much more effective if it reduced or eliminated the fear while the desensitization was in process. It should also be helpful for use during the several other major forms of PTSD treatment that are presently being used.

If nothing more, CES should reduce or eliminate many phobic areas within the personality, allowing the person to come down from his hyper aroused state and begin interacting in more areas of his life experience once again. That would be a type of desensitization therapy process on its own.

Clinical experience has shown that PTSD patients initially never go out without their CES device handy for use at a moment’s notice. The presence of the device gives them a needed feeling of security they can not get in any other way.

Similar uses could be mad of CES in the treatment of Obsessive Compulsive Disorders, whose symptoms also become more pronounced as the patient comes under ever greater amounts of stress. A type of desensitization treatment, Response Prevention Therapy (ERP) has also been found of real value in treating OCD. In this treatment approach, the patient and the therapist record various stimuli that trigger the OCD response, and rate them in terms of emotional valence. They then attack those with less emotional impact by having the patient put himself in the presence of the stimulus, then deliberately refrain from performing the compulsive ritual that is usually attached to the stimulus. Over several trials the patient habituates to the stimulus and it loses its effectiveness in triggering the self-protective, anxiety reducing OC response.

As the therapy progresses, the patient goes on to those stimuli of ever increasing emotional impact. It might well be that CES, in helping the patient control his anxiety when facing each stimulus until such time as it habituated could also synergize this therapeutic approach and shorten the time to recovery.

How much treatment is required to produce these effects with CES? Patients respond to differing amounts of CES treatment, depending on which of their neurohormonal systems CES is intended to rebalance. And while effects begin to be felt from the first treatment, almost all patients are expected to come back within normal homeostatic limits with 60 minutes to 1 hour of treatments every day for 14 to 21 days, depending on the availability of any required neurohormonal precursors in their diet, their level of activity and so on.

By Ray B. Smith, Ph.D.