A Brief History Of Ces
The first CES device, the Somniatron, was developed in the Soviet Union in the early 1900s and delivered 14 mA alternating current at 100 Hz via two electrodes attached to the eyelids . The Somniatron was used to induce analgesia and sleep in patients with insomnia. In 1973, the first CES device was marketed in the United States without formal regulatory oversight, the Electrosone 50, for inducing relaxation and sleep . The Electrosone delivered alternating current at variable pulse frequency with 2 mA to 8 mA intensity the device was portable and battery-operated, and electrodes were placed on the eyelids and mastoids.
Three years after the release of the Electrosone, the United States Food and Drug Administration began regulating medical devices. In 1978, the Neurotone 101 became the first FDA-approved CES device, delivering up to 1.5 mA intensity at 50100 Hz via electrodes placed on the supraorbital ridge and mastoid. The device was marketed for the treatment of anxiety, depression, and insomnia. In the years that followed, several CES devices were developed and marketed in the United States, including the Pain Suppressor, Transcranial Electrostimulator, Electrodorm, Fisher Wallace Cranial Electrical Stimulator, and the Alpha-Stim .
1. Alpha-Stim M
a. Output: Bipolar asymmetric rectangular wave at 0.5, 1.5, and 100 Hz, up to 600 A.
b. Electrodes: Ear clips.
c. URL: .
Quality Of Evidence For Key Question 1
The quality of evidence is presented in . For most conditions, we judged the quality of evidence as being Insufficient, meaning that we cannot even estimate the measure of effect. For one clinical situation we judged the quality of evidence as Low, meaning the true effect may be very different than the estimate of effect. This situation was:
Adverse Events of CES.
Clinical Applications Of Ces
CES has predominantly been used for the relief of symptoms accompanying three clinical disorders: insomnia, anxiety, and depression. While hundreds of studies have been published examining the effects of CES on insomnia, depression, and anxiety, most are inadequately designed and show a high risk of bias according to the Cochrane criteria . To mitigate these biases, in our review we primarily consider placebo-controlled randomized clinical trials with objective measures, similarly to what was done in recent reviews by the Department of Veterans Affairs .
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What To Expect From Treatments
- Anxiety reduction is usually experienced during a single treatment and may last for hours or days thereafter. Insomnia is usually improved after the initial treatment but may take up to 4 weeks to see a significant change. For best results, most people treat at least 3 hours prior to bedtime. It can also be used when awakened during the night.
- Insomnia is usually improved after the initial treatment but may take up to 4 weeks to see a significant change. For best results, most people treat at least 3 hours prior to bedtime. It can also be used when awakened during the night.
- Depression reduction typically takes at least 3 weeks or more of daily treatment to experience significant improvement. Once symptoms have improved, use of Alpha-Stim 2 3 times per week or less is usually sufficient to maintain good results.
Read The Interview Transcript Here:
Dr. Terry Wahls:
Dr. Briley, welcome. I am so glad that youre here, that youre part of the seminar and Im so glad that we have Alpha-Stim joining us this year. Ive been using Alpha-Stim myself for some time and Ive certainly found it to be a game changer for anxiety issues, mood issues for my patients. Its great for pain. So lets talk a little bit about Alpha-Stim.
All right, well thank you. Im excited to be here and to talk about this, so this is great.
Dr. Terry Wahls:
So what is Alpha-Stim and how does it work?
Alpha-Stim is a microcurrent brain stimulator. So what it does is put just a very small electric current with a broad spectrum frequency into the brain and nervous system. And in doing so, its increasing the alpha waves throughout the entire brain and decreasing the Delta waves in the frontal lobe, which leaves you feeling relaxed but alert and kind of just like youve had a really good nights sleep.
Dr. Terry Wahls:
And, do you have any research with this?
Oh, yes. We have more research than any other similar device on the market. We have over 150 published clinical studies going back since 1983.
Dr. Terry Wahls:
Okay, a long time. And, how long do people use it?
A single session can last anywhere from 20 minutes to an hour. In certain situations such as migraines, it may take longer, but most people feel an effect right away.
Dr. Terry Wahls:
Dr. Terry Wahls:
Dr. Terry Wahls:
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Why I Get My Brain Zapped
Conventional therapies haven’t done much good for my anxiety disorder
Almost seven percent of U.S. adultsabout 15.7 million peopleare diagnosed with major depression disorder, according to the National Institute of Mental Health . The Centers for Disease Control and Prevention report that depression causes 200 million lost workdays each year at a cost to employers of between $17 billion and $44 billion. The statistics for anxiety disorders are not great either. The most common mental illnesses in the U.S., they affect 40 million adults age 18 and older, costing the economy more than $42 billion a year.
In my twenties, I developed panic disorder. I failed to get better on most medications and therapy. As I reported in an article earlier this year, it took me years to find a medication that worked. Because it took me so long to be diagnosed and treated properly, I have always been interested in alternative treatments for depression and anxiety.
Two years ago I attended two sessions at the World Science Festival on the use of electrical therapy to treat depression and anxiety. The first event was Spark of Genius? Awakening a Better Brain, a panel discussion moderated by ABC News Chief Health & Medical Editor Richard Besser. The panel discussed what is known about treating the brain and the ethical and legal complications of brain enhancement.
The views expressed are those of the author and are not necessarily those of Scientific American.
Sham Credibility And Blinding
Active CES commonly causes feelings of dizziness, cutaneous tingling or skin irritation at the electrode sites, or light-headedness . In fact, some studies use dizziness or light-headedness as a criterion for identifying the appropriate stimulation intensity for an individual participant specifically, increasing stimulation intensity until the participant reports these symptoms, and then reducing intensity slightly from that threshold . Of course, any sensory habituation achieved during this phase of a study could be changed or eliminated during subsequent phases or sessions. Most studies reviewed here, however, report a static AC frequency and intensity for active CES administration, rather than customizing CES intensity to individual tolerances this is especially the case for non-clinical settings. In our own testing of the Alpha-Stim M, we found suprathreshold cutaneous sensation and vertigo at or above 100 A . We are currently conducting a double-blind, cross-over study to assess cutaneous and vestibular sensations induced via CES at various intensities and frequencies. The possibility that users can readily identify when the device is active vs. inactive increases the likelihood that any attempts at participant blinding to CES conditions will be ineffective, particularly in cross-over designs .
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Risk Of Bias In Clinical Trials
The Cochrane Collaboration has developed guidelines and software tools for assessing the risk of bias in clinical trials . Five domains of bias are identified: bias arising from the randomization process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in measurement of the reported outcome, and bias in selection of the reported result. In our review of the CES literature, we found several examples of these potential biases. Many studies did not use random selection, had missing outcome data due to data loss or participant attrition, used non-standardized outcome measures with high subjectivity, and/or did not comprehensively report all results. For these reasons, reviews of CES effects conforming to the Cochrane guidelines are severely limited in the number of studies that can be included in a review.
For example, in a review and meta-analysis of non-invasive brain stimulation effects on chronic pain, applying the Cochrane guidelines resulted no single CES study being judged as having a low risk of bias . Even when including potentially biased studies, the meta-analysis demonstrated no significant advantage of CES relative to placebo. Similarly, a Cochrane review of CES for headache therapy revealed only one study that fit Cochrane criteria, though baseline group differences limited results interpretation .
Ces For Clinical Insomnia
The four sham-controlled randomized clinical trials using CES to treat insomnia reveal inconsistent results. One study involving 57 active-duty service member participants showed no significant change in hours of sleep time following a 5-day CES treatment relative to sham . This study used the Alpha-Stim SCS device with two electrodes attached to bilateral earlobes, and the sham condition involved an inactive device. No comparative assessment of cutaneous perception was reported. The authors suggested the CES treatment may not have been sufficient intensity to induce reliable effects on sleep, though to our knowledge no follow-up study was conducted.
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Ces Compared To Usual Care
We identified 2 RCTs that compared the use of CES to usual care, that is, not adding a placebo intervention. The first trial was a 3-arm comparison of cranial electrical stimulation using an Alpha-Stim device in 57 patients with fibromyalgia, who were randomized to active CES , sham CES or usual care alone ., Patients were recruited from community rheumatology practices, and had to meet American College of Rheumatology criteria for fibromylagia, have a pain score of 3 or greater on a 10 point numeric rating scale, and be on stable medications for at least 4 weeks. The enrolled sample was 95% female and 89% white, with a mean age of 50.8 years, with an average pain score of 5.8. Subjects in the active and sham group were instructed to use their machine for 60 minutes a day for 8 weeks. The sham devices had been set by the manufacturer to look and act identical to the active devices except that the sham devices did not deliver any stimulation. Over the 8 week course of the study, pain scores in the sham-treated patients and the usual care patients went up slightly, whereas the pain score of the active CES-treated patients declined . According to the authors’ analysis of the slope of the lines of the daily pain scores, the difference between the active CES-treated patients and the other 2 groups was statistically significant . However, our analysis of their data did not show a statistically significant difference in average pain between groups .
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Who We Are Working With
We are working with people with depression, GPs, nurses, mental health specialists, technical experts and companies in the East Midlands and nationally. The device is manufactured by a company called Electromedical Products International, and is distributed in the UK by a company called The Microcurrent Site Limited.
What Is Cranial Electrotherapy Stimulation How Does It Work
Anxiety, depression, sadness, and stress impact your physical health. Chemical reactions in your body are triggered by these emotions and may lead to inflammation and a weakened immune system. Pain, insomnia, anxiety, and depression are all controlled by your bodys central nervous system. It communicates every sensation by conducting electrochemical signals between the billions of cells in your body and brain.
At Delta Discovery Center, we have chosen the Alpha-Stim as our Cranial Electrotherapy Stimulation device because of its unique patented waveform. The Alpha-Stim uses low-level electrical current to safely and effectively treat insomnia, anxiety, depression, and pain.
What Is Treatment Like
When incorporated into in-office treatment plans, treatments take about 40 minutes and the ear clips are simply worn during the majority of your visit. Devices are also available to rent or purchase for at-home use. Treatment set-up is simple and easy to do, and patients can use Alpha-Stim while doing most activities like reading, cleaning the house, etc. Patients can even take it to work with them. The device is portable and the ear clips are unobtrusive it just looks like they are listening to music.
Alpha-Stim uses a mild microcurrent similar to the type and amount of electrical activity naturally occurring in your brain to synchronize brain areas. The microcurrent is tiny, just millionths of an ampere, and so gentle that most people dont even feel it. The device transmits a unique, patented waveform through small clips on patients earlobes that send a mild current through the brain, modulating specific groups of nerve cells. This leads to significant anxiety relief, and mood normalization.
Each treatment builds on the progress of the last. Over time, as patients experience longer and longer periods of relief from anxiety, they often find that they need to use the Alpha-Stim less frequently after the first few 2-3 weeks of treatment.
Used By The Military:
The Alpha-Stim device has been used by the US military for the treatment of anxiety, PTSD insomnia and depression amongst service members and veterans , and was trialled in the UK at the British Armed Forces Rehabilitation Centre in Surrey , following its endorsement by Dr Bob Lister of London Metropolitan University . Dr Kirsch has explained that ‘one of the reasons the military like this product is that many of the psychopharmacological approaches to anxiety have side effects that impair alertness’ .
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Clinical And Cost Effectiveness Of Alpha
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|First Posted : September 15, 2016Results First Posted : June 25, 2020Last Update Posted : July 22, 2021|
This is a single-centre research study in patients seen within an NHS Improving Access to Psychological Interventions service with suspected generalised anxiety disorder . The study will involve 120 patients from the Leicestershire and Rutland area in England, United Kingdom.
Participants will use the Alpha-Stim AID Cranial Electrotherapy Stimulations medical device, which is approved for use and proven to be safe and work for the treatment for anxiety, depression and insomnia.
Participants will use the Alpha-Stim AID for 60 minutes every day for 6 or 12 weeks, either whilst on the waiting list for standard care treatment from IAPT, or in conjunction with standard care treatment from IAPT.
The study will involve 6 study visits – one face-to-face at visit 1, followed by 5 visits via telephone at week 4, 6, 8, 12 and 24. At each visit, participants will be asked to complete questionnaires to assess anxiety, depression, sleep difficulty, quality of life and work and social functioning.