Tag Archives: ces ultra

CES (Cranial Electrotherapy) Studies of Cognitive Function

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.

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.

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 the normal functioning range.

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.

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, 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 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.

By Ray B. Smith, Ph. D.

One more reason to get a good night’s sleep

Sleep. It’s something we spend about a third of our lives doing, but do any of us really understand what it’s all about?

Two thousand years ago, Galen, one of the most prominent medical researchers of the ancient world, proposed that while we’re awake, our brain’s motive force, its juice, would flow out to all the other parts of the body, animating them but leaving the brain all dried up, and he thought that when we sleep, all this moisture that filled the rest of the body would come rushing back, rehydrating the brain and refreshing the mind. Now, that sounds completely ridiculous to us now, but Galen was simply trying to explain something about sleep that we all deal with every day. See, we all know based on our own experience that when you sleep, it clears your mind, and when you don’t sleep, it leaves your mind murky. But while we know a great deal more about sleep now than when Galen was around, we still haven’t understood why it is that sleep, of all of our activities, has this incredible restorative function for the mind.

We’ve found that sleep may actually be a kind of elegant design solution to some of the brain’s most basic needs, a unique way that the brain meets the high demands and the narrow margins that set it apart from all the other organs of the body.

So almost all the biology that we observe can be thought of as a series of problems and their corresponding solutions, and the first problem that every organ must solve is a continuous supply of nutrients to fuel all those cells of the body. In the brain, that is especially critical; its intense electrical activity uses up a quarter of the body’s entire energy supply, even though the brain accounts for only about two percent of the body’s mass. So the circulatory system solves the nutrient delivery problem by sending blood vessels to supply nutrients and oxygen to every corner of our body.

The blood vessels form a complex network that fills the entire brain volume. They start at the surface of the brain, and then they dive down into the tissue itself, and as they spread out, they supply nutrients and oxygen to each and every cell in the brain.

Now, just as every cell requires nutrients to fuel it, every cell also produces waste as a byproduct, and the clearance of that waste is the second basic problem that each organ has to solve. This diagram shows the body’s lymphatic system, which has evolved to meet this need. It’s a second parallel network of vessels that extends throughout the body. It takes up proteins and other waste from the spaces between the cells, it collects them, and then dumps them into the blood so they can be disposed of.

So how, then, does the brain solve its waste clearance problem? Well, that seemingly mundane question is where our group first jumped into this story, and what we found as we dove down into the brain, down among the neurons and the blood vessels, was that the brain’s solution to the problem of waste clearance, it was really unexpected. It was ingenious, but it was also beautiful. Let me tell you about what we found.

The brain has this large pool of clean, clear fluid called cerebrospinal fluid. We call it the CSF. The CSF fills the space that surrounds the brain, and wastes from inside the brain make their way out to the CSF, which gets dumped, along with the waste, into the blood. So in that way, it sounds a lot like the lymphatic system, doesn’t it? But what’s interesting is that the fluid and the waste from inside the brain, they don’t just percolate their way randomly out to these pools of CSF.

Instead, there is a specialized network of plumbing that organizes and facilitates this process. You can see that in these videos. Here, we’re again imaging into the brain of living mice. The frame on your left shows what’s happening at the brain’s surface, and the frame on your right shows what’s happening down below the surface of the brain within the tissue itself. We’ve labeled the blood vessels in red, and the CSF that’s surrounding the brain will be in green. Now, what was surprising to us was that the fluid on the outside of the brain, it didn’t stay on the outside. Instead, the CSF was pumped back into and through the brain along the outsides of the blood vessels, and as it flushed down into the brain along the outsides of these vessels, it was actually helping to clear away, to clean the waste from the spaces between the brain’s cells. If you think about it, using the outsides of these blood vessels like this is a really clever design solution, because the brain is enclosed in a rigid skull and it’s packed full of cells, so there is no extra space inside it for a whole second set of vessels like the lymphatic system. Yet the blood vessels, they extend from the surface of the brain down to reach every single cell in the brain, which means that fluid that’s traveling along the outsides of these vessels can gain easy access to the entire brain’s volume, so it’s actually this really clever way to repurpose one set of vessels, the blood vessels, to take over and replace the function of a second set of vessels, the lymphatic vessels, to make it so you don’t need them. And what’s amazing is that no other organ takes quite this approach to clearing away the waste from between its cells. This is a solution that is entirely unique to the brain. …. From ted.com

Watch more videos – www.youtube.com/cesultra
CES Ultra: The best way to help you get the sleep you need : Effective, safe, and drug-free.
sleep-better-with-cesultra

A View from the Trenches: Why Psychiatry needs CES – Part 1

Why Psychiatry needs CES
by Jason Worchel, M.D.

Jason Worchel, M.D. is a noted psychiatrist and Director of the Hilo Mental Health Center in Hilo, HI. The following posts are taken from a paper written by Dr. Worchel in his testimony before the F.D.A. concerning the effectiveness and safety of CES from the perspective of a practicing psychiatrist.

The Challenge of Psycho-Pharmacology

As a practicing psychiatrist, I am constantly struggling with balancing purported efficacy with known risks of somatic interventions. While currently approved interventions have demonstrated efficacy relative to placebo, the rate of improvement with placebo remains consistently above 30%.

With the increasing prevalence of polypharmacy, there is an increasing risk of adverse side effects for the statistical hope for improved outcomes as demonstrated in clinical trials conducted with select populations in controlled environments. In addition to evaluating the risk/benefits of various treatments, I know from multiple studies most patients are not adherent to the prescribed medication regimens and discontinue medications altogether within a relatively short period of time.

Though my goal is to treat the presenting illness or alleviate its symptoms, my primary duty to my patients is to “do no harm.” This typically results in an approach that follows a spectrum of interventions with initial treatments being those with the least risk of adverse side effects.

There is no risk conventional interventions that currently constitute the standard of care will be bypassed by using CES.

Experience

I have worked with primary care physicians in our federally qualified health clinics on the Big Island. They, like others across the country, are stymied and frustrated by the challenge of treating chronic pain.

In particular, they face patients with bona fide pain but who also have depression, anxiety, insomnia and substance abuse. With regards to treatment interventions, they are damned if the do and damned if the don’t treatment with various classes of analgesic medications, including narcotic medications.

They are particularly afraid of the increasing fatalities occurring with the use of narcotic analgesic medications in combination with benzodiazepines and antidepressant medications. They welcome alternatives to medications for those patients whose emotional distress intensifies their suffering and pain sensation. CES could provide a safe alternative for them that do not currently exist.

In summary, CES represents as safe intervention for conditions for which existing treatments, especially pharmacologic and invasive interventions pose significant risk for adverse side effects. It is especially beneficial in defined populations. These include those who refuse medications and psychotherapy, dual diagnosed patients, geriatric patients, females of child bearing age and during pregnancy.

Advantages of CES

I would like to highlight various advantages of CES relative to other existing treatments, especially medications that may not be well appreciated. Take for example, the difficulty faced by primary care physicians and mental health professionals in treating female patients of child bearing age. All available medications have teratogenic risk and are not recommended during pregnancy and breast feeding. Patients desiring to become pregnant have justified concerns about taking psychotropic medication

cesultra, ces ultra, cranial electrotherapy How To

Current treatment algorithms encourage polypharmacy when initial treatments with a single drug are not effective. While there is some increased response, polypharmacy only increases the side effects burden and can result in untoward drug/drug interactions. These types of problems do not occur with CES.

Many psychotropic medications for the treatments of depression, anxiety and insomnia have discontinuation syndromes. Given the high rate of discontinuation of these medications by patients due to side effects and lack of efficacy, many patients unfortunately suffer when the take a medication prescribed to alleviate their suffering. This does not occur with CES. There are circumstances, for example prior to surgery, when certain psychotropic medications are required to be discontinued. CES does not have to be discontinued prior to surgery.

One my greatest concerns in treating patients with depression, anxiety and insomnia involves suicide. We know increased risk of suicide in depressed patients but it is often global insomnia is a significant risk factor for suicide as well as anxiety/agitation. Although safer than the older tricyclic and tetracylcic antidepressants, the current medications carry a significant risk of death in overdose, especially when combined with other analgesic medications. Too often, the medications we prescribed to prevent suicide become a means through which the patient attempts suicide. In fact, there are black box warnings that these medications may increase suicidal impulses, especially in adolescents. CES does not pose this risk.

As in many developed countries, we are an aging population. The treatment of depression, anxiety and insomnia in the geriatric patients with medications present unique challenges due to the increased risk of adverse side effects. These side effects include the risk of falls and motor vehicle accidents. Again, the number of medications taken in our geriatric patients continues to increase. Thus risk of adding psychotropic medications to their other medications poses additional drug/drug interactions and side effect burden.

CES avoids this disadvantage and provides a safe alternative to patients, their families and care givers. Furthermore, missing a CES treatment does not carry the risks of missing doses of psychotropic medications in this population.

CES Ultra research – read more – http://www.cesultra.com/research-resources.htm

A View from the Trenches: Why Psychiatry needs CES – Part 2

Anxiety

There are many non-pharmacologic interventions for reducing anxiety. Some of these include dietary supplements, acupuncture, meditation, yoga, and exercise. These interventions, however, are not employed by a large segment of society which suffers from anxiety. These persons instead seek medications from their physician to alleviate their suffering.

ces-treat-anxiety

Typical classes of medications for anxiety include the SSRI’s, benzodiazepines as well as the off label use of antihistamines and atypical antipsychotic medications and antiepileptic medications. In addition to the inherent problems with SSRI’s, there are also problems with the other classes of medications.

A serious potential side effect of benzodiazepines is their potential for inducing physical and psychological dependence. In addition, withdrawal symptoms can prove life threatening, especially with the shorter acting benzodiazepines like alprazolam. When taken as directed, which is often not the case; this class of medications can result in compromised coordination, slowed reaction time, falls, disinhibition, delirium, and anterograde amnesia.

It is not uncommon to see suicide attempts involving a combination of a benzodiazepines together with alcohol and/or another sedative hypnotic. While buspirone is relatively well tolerated, it has poor efficacy and a 3 to 4 week lag time to have an effect. Medications such as gabapentin are used off label but there is no research to support its efficacy for anxiety disorders.

Unfortunately, physicians have begun using the atypical antipsychotic medications to treat anxiety. This class of medications has a large and increasing number of very serious side effects. Recent attention has been focused on their causing metabolic syndrome. They frequently cause extra pyramidal side effects, sedation, elevated prolactin levels and drug/drug interactions. All of these medications should be avoided during pregnancy and used with caution in the elderly.

In short, the side effect profile of current pharmacologic treatments for anxiety limits their safe use. CES is a safe, initial alternative to such medications.

By Jason Worchel, M.D., a noted psychiatrist and Director of the Hilo Mental Health Center in Hilo, HI. This post is from a paper written by Dr. Worchel in his testimony before the F.D.A. concerning the effectiveness and safety of CES from the perspective of a practicing psychiatrist.

CES as an effective treatment for pain

Cranial Electrotherapy Stimulation, which has been in use around the world since the early 1950s is an FDA recognized treatment of anxiety, depression and insomnia.  Many patients and their physicians have also discovered that it is a very effective treatment for pain.

ces-treatment-pain-depression

It has been theorized that CES is effective in pain treatment because it is known to relieve stress, and stress is known to be a strong correlate of the perception of pain in pain patients.

ces-treatment-pain-depression

Recently it has been shown that pain is also a frequent accompaniment of depression, which CES is known to treat very effectively. In one study more than 75% of patients being treated for depression reported experiencing chronic, or recurring pain, and 30% to 60% of pain patients studied, also reported significant depression.

ces-treatment-pain-depression

Presented by cesultra.com