Tag Archives: cranial electrical stimulation

Transcranial Direct Stimulation v. Cranial Stimulation

It is perhaps time to set the record straight about transcranial direct current stimulation, commonly known as tDCS and the sudden rush to embrace this new technology.

There is a serious misunderstanding which should be done away with at the outset. tDCS is not ECT ( electro-convulsive therapy). We are talking instead about a totally different modality. Further, within that modality, yet another distinction should be made. There is tDCS ( transcranial direct current stimulation) and CES (cranial electrical stimulation) which is based not on DC but on AC ( alternating Current).

Much of the current ( no pun intended) hoo-hah is about tDCS  and specifically the device being marketed by foc.us. It is based on research of a dubious nature and promoted as a new hula-hoop for the mind for gamers and those hoping for a quick cognitive fix.

Though it affects the human condition, the FDA has not intervened to regulate the device, primarily because its sponsors make no medical claims. It has also not been adequately tested for safety, though the amperage, being as low as it is in all probability harmless. Due to the absence of studies, very little is known about the long term effects of tDCS on developing brains.

CES ( cranial electrotherapy stimulation) is also a hand-held electronic device that is simple to use and has no side effects. Unlike tDCS, however, CES, however, has been around for more than half a century, has a substantial body of solid scientific research behind it, as well as an unblemished safety track record. CES manufacturers are registered and monitored by the FDA and are allowed to make claims for their device for the treatment of anxiety, depression, and insomnia. Though no claims are made about enhanced cognitive functioning, results demonstrate gains in that realm as well.

cesultra cranial electrical stimulation

Common sense says that cognition is very much a function of those states. If you are less anxious and depressed and getting a good night’s sleep, your cognitive     functioning improves as well. Conversely, the more stressed out you are, the less able you are to think clearly. It is somewhat depressing as one who has worked in the field for more than 35 years to encounter a discussion on the brain and electrical activity and hear not a word about CES. Incidentally, at a time when our veterans are struggling to find a non-drug solution to PTSD, CES is being currently used exactly for that purpose, being prescribed for active duty personnel returning from the mid-east at the Warrior Combat Stress Reset Program at Ft. Hood, TX, at Ft. Campbell, KY, Ft. Joint Ft Lewis-McChord, WA, at the Bremerton WA Naval Hospital, as well as in combat conditions in Iraq and Afghanistan. When it comes to employing gentle electrical stimulation for the treatment of depression, anxiety, and insomnia as well as an associated upswing in cognitive functioning, using a government regulated modality, CES is clearly the only viable option.

CES being used in pain clinics

CES units were becoming more widely used in pain clinics at the dawning of the 21st century. The clinics typically do not wait for pain studies to be completed, but simply try CES with their patients to see what effect they can observe, then compare it with their historical experience with those same types of patients. A typical such clinic is one just outside Dallas, Texas. A nursing assistant puts CES electrodes on patients as they enter the waiting room to await their turn with physicians or other therapists. The wait can vary from a few minutes to a half hour, depending on the patient load at a given time. The patients complete a 10 point self rated pain score prior to receiving CES. When they are called into treatment by the treatment staff, the CES is removed, the amount of time they were on the device is recorded, as a post CES self rated pain score if obtained.

The clinic has become so enthusiastic about the results, that this protocol has become a permanent part of their core treatment program. They now enthusiastically prescribe CES home units for their large number of patients who now request them, and the staff reports their clinic is much more effectively treating chronic pain than they were previously.

Pain clinic treatment results have been published, however. An interesting CES study was completed in a pain clinic near Bombay, India, in 2001. It was an open clinical trial of CES, used alone as a treatment of pain patients who had been refractory to all other previous efforts of treatment of their pain at the clinic. They were given CES treatments one hour per day, 5 days a week, for three weeks. They were asked to rate their pain level on a VAS scale of 0 to 10, with 10 being the most intense pain. Following treatment their mean self reported pain level had been reduced by 62%. Analyzing the data for individual patients it was found that 15% of the patients did not respond to the treatment, 30% gained total relief, while the remainder of the patients claimed significant relief ranging from 33% to 94%.

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.

Operation Pro-Vet

The Problem

Tens of thousands of Iraqi and Afghan veterans have returned home from the wars with a debilitating condition: post-traumatic stress disorder (PTSD. The VA is at loose ends about how to deal with a mental health crisis that is ruining not only the lives of returning vets, but those of their families and friends as well. Drug therapy, which is the main way they have treated the problem, has proven to be not only ineffective, but has worsened the situation, triggering an extraordinary spike in substance abuse, leading to violent behaviors and suicide.

cranial-stimulation-prevent-suicide

Read Brig. General (Ret) Stephen Xenakis MD, on the plight of our veterans at Huffingtonpost – PBS’s ‘This Emotional Life’: Memorial Day — Remembering Military Suicides

Watch General Xenakis on Fox News, discussing how CES can help treat PTSD at FoxNews – Can Brain Stimulation Help with PTSD?

An Answer?

Fortunately, there is a non-drug option with a proven track record in treating anxiety, depression, and insomnia which are the primary symptoms of PTSD. It’s called cranial electrotherapy stimulation, or CES. It’s an electronic device that is simple to use, has no side effects, and has been validated by decades of research. CES is currently being prescribed for active duty personnel returning from the mid-east at the Warrior Combat Stress Reset Program at Ft. Hood, TX, at Ft. Campbell, KY, Ft. Joint Ft Lewis-McChord, WA, at the Bremerton WA Naval Hospital, as well as in combat conditions in Iraq and Afghanistan. It should not stop there.

Operation Pro-Vet: How You Can Help

CES units generally retail for $350-$995. Because they are not generally covered by health insurance, they are most often out of the reach of veterans most of whom have a limited income or who are currently unemployed. Neuro-Fitness LLC, the manufacturer of the CES Ultra—in recognition of those who have given so much for their country—will now make available its CES unit at wholesale cost to veterans, not only of our current wars but our past wars as well as to their families. We are also working with Service clubs to make available units at a special low cost so that they may then be distributed to veterans in need.

To learn more about CES, visit us at our website: https://www.cesultra.com/. To learn more about the program, call us at 1-425-222-0830 or email us today at sales@ cesultra.com for more information and how your local group or organization can become part of this program to assist those who have served on our behalf. They deserve nothing less.

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.

More CES Research – https://www.cesultra.com/research-resources.php