Table of Contents
- Brain Tuner
- Benefits of Brain Tuners
- Cranial Electrotherapy Stimulation
- Study by the VA Evidence-Based Synthesis Program
- What Are the Results in the Real World?
Before we delve further into CES therapy and brain tuners, we need to look at its origins. In the early 1970s, Margaret Angus Patterson or Meg Patterson, a Scottish surgeon, came up with a technique she referred to as neuro-electric therapy (NET) to treat addiction based on an electroacupuncture treatment developed by her colleagues at the Tung Wah Hospital in Hong Kong. This method gained in popularity through the 70s and 80s because of the several endorsements it received from rock and pop stars of the generation. The likes of Eric Clapton, Rolling Stone’s Keith Richards, The Who’s Pete Townshend and Boy George claimed over the years that her technique cured their heroin addiction. As part of this detox treatment, two electrodes were placed behind the ears and the slightly electric current that was delivered produced endorphins and other neurochemicals in the brain. Apparently, the endorphins also took care of the usual withdrawal symptoms that addicts trying to get clean have to deal with.
NET is one of the primary antecedents to the brain tuner. However, there are several other forms of transcranial electrical stimulation (tES) that have been developed over the years. It needs to be mentioned here that the healthcare system in Scotland, NHS Scotland, had conducted a thorough study of NET and concluded that there was no evidence to suggest that it was effective in treating addiction, especially opiate addiction.
The brain tuner or bio tuner as we know it today was developed by Robert Beck or Bob Beck, who is mainly known as the person behind the technique known as blood electrification. Besides NET, Beck also looked at the electrotherapy system and machine developed by James Ray Gilmer and Neuro Systems Inc. while creating the brain tuner.
This device looks similar to a pair of earphones and the ear clips at the ends attach to the ear lobes. The ear clips are equipped with conductive rubber electrodes that deliver the harmonic frequencies. It’s typically worn for periods of 20 to 40 minutes per day for 30 days back to back for best results. According to Beck, the brain tuner delivers a set of frequencies and wave forms at measured repetitive rates to stimulate the production of certain beneficial neurotransmitters in the brain.
There are other iterations of the brain tuner as well. For example, take this tuning forks based brain tuner from Biosonics. One tuning fork is held near the left ear and another near the right ear and are sounded simultaneously, which leads to the creation of a binaural beat.
The binaural beats concept has also been utilized by a number of app developers and online content creators to create brain tuning apps and autonomous sensory meridian response (ASMR) videos that claim to help people fall asleep or feel a relaxing sensation.
The makers of brain tuners claim that the device can help people deal with a number of issues. However, it’s worth noting that there isn’t enough evidence to prove any of these benefits.
- Stress Relief: The harmonic frequencies have a calming, relaxing effect on the nervous system, which in turn helps reduce stress levels.
- Sharpness and Clarity: The neurotransmitters produced inside the brain also help in improving mental sharpness and brings forth clarity of thought.
- Addictions: As with NET, the brain tuner also helps deal with addiction, especially the withdrawal symptoms associated with the rehabilitation process.
- Insomnia: As mentioned earlier, the brain tuner calms the mind and body, which also helps people suffering from insomnia get better quality of sleep.
- Mediation: If you have been struggling in your attempts to meditate, then this device can help by improving focus and attention spans.
- Pain Management: The relaxation and overall balance inside the body also helps deal with pain better.
Therapeutic devices that administer cranial electrotherapy stimulation (CES) were first granted approval by the US Food and Drugs Administration (FDA) in 1979. The FDA allowed the use of CES to treat insomnia, depression and anxiety. Over the years several controlled studies have been conducted to learn more about CES therapy and how effective it is in dealing with chronic pain, fibromyalgia, anxiety, etc. These studies have demonstrated that applying low-intensity current on either the earlobes or scalp can be beneficial to a certain extent. At the same time, there are other studies that say that there’s insufficient evidence to suggest that CES is effective in dealing with depression, chronic pain, anxiety or insomnia.
However, more importantly, even when a study has provided empirical evidence regarding the clinical efficacy of CES therapy, it has failed to illustrate how the therapy actually works, which has been a consistent stumbling block. What that means is that once the current is applied the studies have been able to measure the changes it brought about, but failed to determine conclusively the underlying principles and mechanisms that enabled these changes.
The FDA, which had initially approved the commercial sale of such therapeutic devices for personal use, has been forced to reconsider. In 2012, the FDA’s Neurological Devices Panel began debating whether these devices should be reclassified to Class III with premarket approval (PMA). A Class III classification requires the manufacturers of these devices to provide sufficient evidence of both its effectiveness and safety before a PMA can be provided. The other option was a Class II classification, which is less stringent. The FDA had withdrawn its PMA requirement for CES devices in 2014, but as of April 2018, these devices continue to be classified as Class III with PMA by the FDA. Due to this classification, one can only buy a CES device if they have a valid prescription from a healthcare practitioner with an electrotherapy license.
This program, which was funded by the Department of Veterans Affairs, examined a total of 28 published articles which described 26 different randomized trials of CES to determine the effectiveness of CES and the risks and safety issues related to CES. Anecdotal evidence suggested that there had been an increase in the demand for CES devices among veterans. Hence, this study was commissioned. The study explored two key questions.
The study found that when the effectiveness of CES is compared against sham or fake devices, there was a marked increase in the beneficial effects being recorded. However, when compared to the regular methods of treatment there was little to no difference. In many cases, the subjects were also undergoing other forms of treatments and therapy as well.
- The results of the effectiveness of CES in case of painful conditions such as fibromyalgia, headache, degenerative joint disease, chronic low back pain, etc. were mixed and there was a high risk of bias.
- In case of depression and anxiety, only one of the randomized trials provided any form of evidence that CES can be an effective treatment. All the others were either too old or didn’t prove effective.
- There was no evidence found in the trials to suggest CES is as effective as standard treatments for insomnia.
- Overall, the study found insufficient evidence to suggest that CES is as effective as standard treatments for headache, fibromyalgia, pain with spinal cord injury, neuromusculoskeletal pain, degenerative joint disease, bipolar depression, insomnia, anxiety and insomnia and anxiety.
- Only in case of anxiety and depression, the evidence was low as opposed to insufficient.
What Are the Risks Associated with CES as Compared to Standard Treatments for Chronic Pain, Depression, Anxiety, PTSD and Insomnia?
Out of the 26 trials that this study took into consideration, only 10 had reported adverse effects of CES and safety issues. Of these 10 trials, 6 had noteworthy adverse effects to report.
- In one trial, a number of subjects who had undergone CES reported poor concentration and a feeling of discomfort or unease. And nearly one-third of the subjects also reported that they saw a mild flashing light in their peripheral vision as well as a tingling sensation on their scalp.
- In another trial, the subjects reported that they felt a variety of sensations, including pulsing and tingling sensations on their ears, needle pricking sensations near their bladders and their ears felt tender.
- The pulsing of ears, tingling sensation and itchiness was also reported by subjects of another study.
- A sensation of irritation on the scalp, dizziness, headache and seeing something flickering was reported in one trial.
- A number of subjects who had been given sham or fake CES treatment, across several trials, complained about feeling drowsy or sleepy.
- Overall, the primary side effects of CES seem to be tiredness or sleepiness, irritation of the skin and certain momentary visual symptoms.
People who suffer from depression and anxiety have written about their experiences of using different CES devices. One person who has been using a FDA-approved CES device made by Fisher Wallace for over six years at the time of publication, wrote on the Scientific American that he uses it to deal with his anxiety issues, chronic pain and once in a while to deal with insomnia. He mentions that using the device relaxes him and it doesn’t feel as if he’s shocking his brain. One of the key things he mentioned was that unlike some of other forms of electrotherapy, a CES device can be used at home and there are very little side effects. More importantly, he also mentioned that medications such as Prozac, Zoloft and Lexapro didn’t work him and cognitive behavioral therapy is too expensive for most people.
Another person who has been suffering from panic attacks, anxiety and depression from her teens and has been using the Alpha-Stim CES device for over a year at the time of publication, wrote on Health.com that during her first session she felt a buzzing sensation similar to consuming about half-a-glass of wine. She mentioned that this was a calming sensation, but it didn’t last long. During her second session, she experienced the same calming sensation and the effect lasted through the day. During this year, she hasn’t experienced a single panic attacks and she mentions that there has a marked improvement in her overall mood and she sleeps better at night. She too had been on Prozac and that helped her initially, but once the dosage was increased she experienced side effects such as restlessness and agitation, which affected her mood.
The studies and research into CES is limited. While some studies have been able to identify the positive effect CES has on issues such as depression and anxiety and can also help improve concentration levels, but they have failed to determine why CES has this effect. At the same time, there are very limited side effects or adverse effects of CES therapy, at least based on the studies conducted so far. Thus, it can be used by people to help them deal with these issues. However, it can’t the primary method or technique of treatment. It needs to done in conjunction with the established standard treatments. Plus, it makes sense to consult a healthcare practitioner before investing in a CES device. The Fisher Wallace Stimulator costs $399 with a 30-day return and refund policy, while the CES devices made by Alpha-Stim cost between $795 and $1,195. If you do decide to give CES a try, remember to limit the sessions to no longer than 20 minutes per day and do not expect any magical cure for the issues you are grappling with. If you’re someone who likes listening to music and if it has a calming influence on you, then think of CES along similar lines.