Cranial Electrotherapy Stimulation (CES) for Anxiety

James Lake, MD - cranial electrotherapy

Cranial electrotherapy stimulation (CES) has beneficial effects on many mental problems

Micro-current electrical stimulation, also called cranial electrotherapy stimulation (CES), has been approved by the U.S. Food and Drug Administration for treatment of insomnia, depressed mood, and anxiety but is not widely used or recommended by psychiatrists and other mental health providers. Treatment consists of applying very weak pulsed electrical current to the earlobes or scalp.

CES changes the brain’s default mode network

The mechanism of action is probably related to changes in cortical brain activity that cause altered connectivity in the so-called ‘default mode network (DMN) (Feusner 2012).’ Small changes in the DMN translate into sustained changes in the brain’s resting state and overall level of arousal resulting in reduced anxiety.

Research findings are positive

Sham-controlled studies and meta-analyses show that CES is a safe and effective treatment of generalized anxiety. A meta-analysis of double-blind controlled trials comparing CES with a sham treatment (ie, electrodes applied but with no current) concluded that measures of generalized anxiety improved in 7 of 8 studies, and the magnitude of improvement reached statistical significance in 4 of these. A larger review encompassing 34 sham-controlled trials conducted between 1963 and 1996 concluded that regular CES treatments resulted in short-term symptomatic relief of generalized anxiety symptoms mediated by direct effects on autonomic brain centers (DeFelice 1997). In a 10-week open trial of daily self-administered CES therapy in 182 individuals diagnosed with DSM-III anxiety disorders, 73% of patients reported significant reductions in anxiety that were maintained at 6-month follow-up. Significantly, one-fourth of patients enrolled in this study had failed trials on conventional drugs, and 58% had received no previous treatment of any kind for their anxiety symptoms. In general, patients who receive at least 4 to 6 CES treatments experience more sustained reductions in anxiety compared to patients who receive fewer treatments.

Individuals diagnosed with one or more phobias by DSM criteria reported significant reductions in transient anxiety when exposure to the phobic stimulus was followed by 30 minutes of CES treatment. Comparable anxiety reduction was achieved with CES and conventional anti-anxiety medications suggesting that CES may be an effective approach for phobic patients who wish to discontinue prescription medications. Hospitalized patients with histories of drug or alcohol abuse reported significant reductions in anxiety compared to matched patients who received sham CES.

Few mild transient side effects but no serious adverse effects of micro-current electrical brain stimulation have not been reported.

by James Lake, M.D. who works to transform mental health care through the evidence-based uses of alternative therapies. Ref: https://www.psychologytoday.com

Clinical trial of Cranial Electrotherapy stimulation in adolescent patient with depression, anxiety and developmental deviation

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Justin is a sixteen year old Caucasian male with a history of psychiatric treatment including medication intervention for developmental deviation with a hyperkinetic element. His history of school functioning had been very poor with low motivation to succeed. His father reports that Justin would often experience feelings of anger and anxiety with behavioral acting out. During the initial psychological evaluation he had great difficulty attending to tasks presented to him, was emotionally labile, and on a measure of depression he scored at the 24th percentile, while on a measure of anxiety he scored at the 2nd percentile with present moment (state) anxiety and at the 27th percentile with general proneness (trait) anxiety. On the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Full Scale intellectual functioning was in the Average range (Full Scale IQ = 96) with verbal area functioning in the Low Average range (Verbal IQ = 81) and performance area functioning in the Superior range (Performance IQ = 122).

After thirty days daily usage of at least forty-five minutes with the CES device he was again administered a psychological evaluation. On the same measure of depression Justin scored at the 1st percentile, while on the same measure of anxiety he scored at the 3rd percentile with present moment (state) anxiety and at the 16th percentile with general proneness (trait) anxiety, a noticeable decrease with his levels of depression and trait anxiety. On the WAIS-R Full Scale intellectual functioning was in the High Average range (Full Scale IQ = 111) with verbal area functioning in the Low Average range (Verbal IQ = 88) and Performance area functioning in the Very Superior range (Performance IQ = 139). Higher scores in the Verbal, Performance, and Full Scale areas indicated a gain of more than three standard deviations which by chance alone would occur in less than two in ten thousand cases (p<.0002). He was observed to be much more at ease with a noticeable improvement in his affect and cooperativeness as well as his ability to not only stay on task, but more motivation to do well with tasks. His mother stated that his ability to tolerate difficult situations and tasks was greatly improved as was his mood and that it was much easier and more pleasant to be around him.

Dynamics of the Cranial Electrotherapy Stimulation Devices Market

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With the increasingly stressful lifestyle there is also rise in other types of disorders such as anxiety and sleep disorders. With the lack of sufficient treatments that address these disorders, cranial electrotherapy stimulation comes as an innovative and required treatment.

Cranial Electrotherapy Stimulation (CES) device is a small device that stimulates the cranium and brain with a current less than 4 mA, which cannot be sensed by the patient. The cranial electrotherapy stimulation is approved by the FDA for the treatment of insomnia, depression and anxiety. Besides, it has potential application in the treatment of a number of disorders such as attention deficit hyperactivity disorder (ADHA), obsessive-compulsive disorder, post-traumatic stress disorder (PTSD), cognitive dysfunction, traumatic brain injury, pain, enhancing attention and concentration, and for reducing assaultive behavior.

A relatively large number of the population across the globe is diagnosed with such disorders. A significant portion of the U.S. population is affected by poor mental health, which leads to development of various kinds of mental health disorders. The treatment method is complementary and an alternative of medicine. There are large number of clinical trials currently active, which have proved the CES device as an effective treatment method.

The increasing number of cases of poor mental health with the development of disorders such as depression, anxiety and other sleep disorders is driving the growth of the market. Although animal studies have proved this device to be effective, the adoption of these devices is affected due to lack of strong evidence in humans proving the efficacy of the devices in all or most of the cases. However, there are a number of new clinical trials in the recruiting stage, which may help fill the gap in the market.

Use of Cranial Electrotherapy Stimulation in Hospitals and the Growing Demand of Wearable Type of Devices

There are various types of cranial electrotherapy stimulator devices and they can be broadly classified based on the type of electrode placement, such as invasive or transcranial and non-invasive or wearable. The wearable type is the dominant segment in the market. The wearable type device is user-friendly and does not requires surgical insertion of the electrode. Most of the FDA-approved devices are suitable for the treatment of insomnia, depression and anxiety, as the prevalence of these disorders is increasing, in which depression is the most common and growing disorder in the young population. Since most of these devices are available only in prescribed hospitals and mental health clinics, they have a large scope as end-use segments in the market.

The CES Ultra is one of the three major cranial electrotherapy stimulation devices, namely the CES Ultra by Neuro-fitnesss LLC, Alpha-Stim M and the Alpha-Stim AID by Electromedical Products International (EPI), and the Fisher-Wallace Simulator.

The CES Ultra is most affordable and effective easy to use CES device. You can buy directly from us, Neuro-fitnesss LLC, the manufacturer, without a middleman, and save time and money.

Why Pay More?

A few words of advice if you’re looking to purchase a CES unit: There are only a few FDA approved companies selling CES in the U.S. Here are the companies and their devices:

  • Neuro-Fitness LLC/ CES Ultra
  • Fisher Wallace, Inc./Fisher-Wallace Stimulator
  • Electromedical Products International, Inc./Alpha-Stim

Below is a price comparison table:

ces-devices-prices

Do not be fooled into paying more, because you think more is better. The FDA (Food and Drug Administration) considers all approved CES units to be “substantially equivalent” to each other.

Note: *The CES Ultra is the premier unit on the market. It alone features the original 100 Hz configuration that most of the CES research has been done on. Other units may claim to carry the 100 Hz but no other unit has an accurate rendition of the configuration on which most of the research is based.

WARNING

Do not buy product that are not approved by FDA (The Food and Drug Administration)

You may also find certain “underground” instruments on the market, particularly on the Internet. Contrary to their anecdotal claims, most have no scientific evidence behind them. Many are nothing more than low-cost pulse generators of dubious quality, and have not been fully evaluated for either efficacy or safety. They are not registered with the FDA. Many are billed as “for research purposes only,” and cannot legally be called “medical devices” or make any medical claims. Many are from overseas and are of dubious quality.

Student received a big boost through CES Ultra

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Sarah, a seventeen year old female in the eleventh grade, states “Now I take more time to think about things (i.e. vocabulary words) and I spend more time and take more steps to remember them than before”. She is also reported to take more time to insure she has followed all the necessary steps and test taking skills in biology and history are improved in her improved ability to completely read questions and formulating better thought out written answers.

She reports wearing the device while taking tests “It relaxed me. I remember coming into the class with a headache. By the time I finished the test the headache was gone.”

After working daily with an educational therapist for fifteen days with application of the CES device for at least
forty-five minutes daily she was successful for the first time in memorizing two pages of lines in a skit, demonstrated improved math skills and comprehension of biology concepts. Sarah states that she would not have been able to accomplish this without the use of the device. Self confidence also improved and fear of test taking was greatly decreased if not eliminated. Her grades are now in the B range where formerly they were in the D to F range. intervention was also associated with the cessation of a difficult premenstrual tension syndrome. She reports no further menstrual cramps since using the device and states “I am not witchy anymore” during her menstrual periods. She states that she is no longer bothered by the chronic fatigue that so dramatically affected her earlier learning efforts.