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.
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.
Military personnel experiencing post-traumatic stress disorder (PTSD) symptoms from trauma faced in the line of duty often go many years without seeking treatment. Sgt. Dwayne Sawyer suffered from PTSD symptoms for five years before he sought help, while Leading Aircraftsman J. Smith (name changed to protect identity) suffered from the late 1950s until four years ago. Even with medical assistance, some may not experience relief from their symptoms, while others won’t seek help because of the stigma attached to the diagnosis of PTSD.
Fortunately, there is an emerging technology that is non-addictive and has outstanding results, helping 85% of trauma sufferers who use the device regularly. There are several devices on the market, the most accessible being the Sleep Genie. It uses cranial electrotherapy stimulation (CES) technology to stimulate the relaxation centre of the brain, helping the user to sleep better, which in turn, alleviates some of the symptoms related to PTSD. According to Eileen Jones’ 2006 research paper Cranial Electrotherapy Stimulation, A Non-Drug Neuromedical Treatment, the device works by sending a low intensity microcurrent to the brain. The unit is designed for home use: the user fastens two clips behind the ears from a hand-held machine.
Several doctors in Canada are using CES as part of their therapy. In Barrie, Ontario Dr. Jonathan Douglas, (Ph.D., C.Psych) became aware of the technology in 1998. He looked into it for a number of years, analyzing the research before trying it as a part of his practice. He began using the Alpha- Stim in his office and then purchased several Sleep Genie units to lend out to his clients for home use. Dr. Douglas explains the deciding factors for using this technology: I use it based on the presentation of the client – do they have difficulty falling asleep? Are they anxious or depressed? Do
Sgt. Sawyer was experiencing sleeplessness due to flashbacks and nightmares; PTSD symptoms that resulted in sleep avoidance. I didn’t want to fall asleep because I didn’t want to relive the trauma, explained Sawyer. As a result, he was exhausted all the time and spending $75-100 per day on high dosage sleep medication. He wanted off the medication.
It’s a big thing for a lot of the guys. You don’t want to be medicated when you don’t have to be.When his therapist recommended CES therapy, Sawyer was skeptical at first, thinking there is no way this will work. He noticed results after just a week, and after six weeks he was getting a full night’s sleep and had more energy during the day. He uses the CES device for 20 minutes per week while he watches television. He still gets flashbacks and nightmares, but nothing to what it was before. Life is slowly coming back to normal again. I can keep my symptoms under control now. It saved my wife and kids.
Leading Aircraftsman Smith wasn’t skeptical about the CES device when his therapist recommended it. He was fed up with his symptoms. He explains, I’ll try anything to help. After three years of using the technology regularly, he still experiences his PTSD symptoms on and off, but they are not as severe as they were before.
Dr. Ken Welburn, Ph.D., C Psych, the clinical director of a trauma clinic in Ottawa, has been educating therapists for 20 years about the psychiatric symptoms of trauma. He explains that cranial electrotherapy stimulation is a widely researched area. Since the technology was invented in the 1950s in Russia for sleep problems, many scientific studies have been done and are very conclusive that it is an effective treatment of insomnia, anxiety, depression, and certain types of pain. He was impressed with the research on CES devices, especially that there are no serious side effects, so he purchased a unit and tried it on himself. He experienced better quality sleep and felt a calm focus during the day.
Dr. Welburn started a study with his clients, using the variables: sleep latency, numbers of hours spent asleep, disturbance in sleep, and sleep deprivation during the day. He evaluates his clients based on this criteria before they use the CES device and interviews them every week for the eight weeks using the device. There is a pronounced effect, a dramatic change in these variables. He explains that, to PTSD sufferers, sleep is a dangerous place so you try to avoid it. He finds that continued use of the CES unit helps his clients to better handle stress without overacting to change emotionally. Dr. Welburn notices the biggest changes in sleep quality, anxiety levels, and the improved ability to focus. It is a great tool for treating trauma and for helping manage the symptoms my clients are experiencing. It is not the whole therapy but part of it.
Both doctors believe that the use of medications for sleep, anxiety, and antidepressants can be drastically reduced with continued sessions. But they also say its important to keep in mind that changes occur over time and with continued use. As Dr. Douglas explains, there is never going to be a cookie cutter approach for any situation. Some people will not find relief in the technology. Dr. Welburn finds that approximately 85% of people respond positively to the treatment, while Dr. Douglas found that since his introduction of the CES device in 2006, only three patients have had a negative reaction.
The Sleep Genie (now the CES Ultra device) can be purchased directly from the company but it is recommended people use it in conjunction with therapy. It is not recommended that you use the device if you are pregnant or if you have a pacemaker. Dr. Welburn explains, there have never been any adverse side effects in these cases; it is just a precaution.
The Food and Drug Administration (FDA) has agreed to propose approval and reclassification of cranial electrotherapy stimulation (CES) devices for the treatment of insomnia, depression, and anxiety. In a document to be published tomorrow, the FDA says it is withdrawing the proposed rule it issued in the Federal Register of August 8, 2011, and the proposed order it issued in the Federal Register of April 4, 2013, in part. In those documents, FDA proposed to require the filing of a premarket approval application or a notice of completion of a product development protocol for the class III preamendment device, cranial electrotherapy stimulator. In response to information received in response to these two proposed actions, FDA is withdrawing the proposed rule and proposed order.
“This decision is a watershed moment in the history of CES and demonstrates that the FDA is committed to supporting scientifically proven alternatives to drug therapy for the treatment of insomnia, anxiety and depression—the three symptoms most common to sufferers of post-traumatic stress, many of whom served our country in Iraq and Afghanistan,” says Chip Fisher, president of Fisher Wallace Laboratories, which makes the Fisher Wallace Stimulator. “We applaud the Agency’s position and look forward to the months that follow as the regulatory process unfolds.”
He adds that there are several steps which must occur before the Agency officially approves CES, including the FDA’s formal proposal for reclassification and the public comment period following such a proposal. “But today the FDA stated that it has determined ‘that there is sufficient information to establish special controls, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness for CES devices…FDA plans to issue a proposed order in the future for the reclassification of the CES device into Class II,’” Fisher says.
Lawrence Paros, President of Neuro-Fitness LLC manufacturer of the CES Ultra ( www.cesultra.com) , concurred: “This is the culmination of almost a half century of effort to gain credence for an effective non-pharmacological modality for the treatment of stress and stress-related disorders. It has the potential to revolutionize the treatment of substance abuse and PTSD with none of the negative side effects of drugs and provide a safe and effective low cost approach to medical issues besetting millions of our citizens. . The FDA is to be commended for its foresight in verifying its legitimacy and the science behind it.”