Technology has caught up enough with Transcranial Magnetic Stimulation (TMS) and Repetitive transcranial magnetic stimulation (rTMS) that wearable brain stimulation technologies are on the market, developers of the innovative devices says.
The newer technologies allow patients to treat their depression and other conditions at home for less money than traditional TMS therapies and with similar - or even better - results.
"Our wearable device actually delivers the same stimulation frequency as rTMS in published research: 15 hertz," Kelly Roman, co-founder of Fisher Wallace Laboratories, said about that company's Food and Drug Administration-cleared TMS alternative, the Fisher Wallace Stimulator.
The Fisher Wallace Stimulator's key advantage over traditional TMS therapy is that a doctor's office visit is not required, Roman said.
"You need to go to a clinic to receive TMS because TMS machines are large and require a doctor to administer them," Roman said. "If it wasn't so inconvenient and expensive, I think a lot of psychiatrists would prefer TMS be used more frequently by patients - you can't feasibly or affordably go to a TMS clinic twice a day, every day, for weeks. But you can easily have that treatment frequency with a wearable."
Patients still need to do their homework to be sure which at-home TMS alternative might be right for them, Marom Bikson, co-founder of Soterix Medical said in reference to his company's devices.
"When comparing technologies like TMS and transcranial Direct Current Stimulation (tDCS), the best neuromodulation treatment option for any patient will depend on the patient's symptoms and goals," he said.
Patients currently have a growing number of devices from which to choose. Another brain device, cranial electrotherapy stimulation (CES) stimulates the brain with a current the user can't otherwise sense with typical dosage, is finding increasing use for treatment of anxiety, depression and insomnia.
TMS was first introduced in 1985 and has been studied as a form of treatment for a number of psychiatric disorders, including depression, obsessive compulsive disorder, Tourette syndrome and in reducing auditory hallucinations in schizophrenia patients. In July 2011, the FDA issued a special controls document for Repetitive Transcranial Magnetic Stimulation (rTMS) Systems to provide guidance for the burgeoning industry and its own staff.
The advantages of TMS are that is it non-invasive, non-surgical and it has a low rate of side effects. A large, double-blind controlled clinical trial conducted in 1999 found TMS to be more effective than a placebo. In August, the FDA announced it would permit the marketing of the Brainsway Deep Transcranial Magnetic Stimulation System for treatment of obsessive compulsive disorder.
The disadvantages of TMS is that it often is out of reach of patients because it is an expensive treatment not always fully covered by insurance and its nonportable equipment requires a doctor's visit, in addition to having to be administered by a psychiatrist. The cost can be especially arduous for patients because insurance rarely pays for more than a dozen treatment sessions and out-of-pocket costs can top more than $15,000.
Meanwhile, many patients report the effects of TMS treatments wear off after months or even weeks.
Fisher Wallace Laboratories, founded in 2007, manufactures FDA-cleared, wearable neurostimulation technology intended to treat depression, insomnia, anxiety and chronic pain. Fisher Wallace recently announced development of KORTEX, the first virtual reality neurostimulation platform for consumer health care.
Soterix Medical, founded in 2008, is an international company specializing in clinical trials for non-invasive neuromodulation with more 350 medical centers in the U.S. and around the world. Soterix has developed a comprehensive intellectual property portfolio that includes High-Definition transcranial Direct Current Stimulation (HD-tDCS), Limited Total Energy tDCS (LTE-tDCS) and Neurotargeting Software.
In 2016, Forbes called Fisher Wallace one of four companies to watch as it develops "technology to creatively provide solutions to treat mental health issues and promote mental health wellness."
Fisher Wallace's Stimulator has been observed to be especially effective for treating bipolar depression, Roman said.
"In the clinical trial we performed at Mount Sinai Beth Israel Hospital, we saw a very large difference between the effectiveness of our device versus a placebo device," he said. "All the patients who used the placebo device returned to baseline within two weeks, whereas the patients using the active device - the real device - had durable reduction in depression."
Soterix Medical's more-portable TMS alternatives also provide the benefits that can be expected from the bulkier, in-office devices, Bikson said.
"While tDCS is also offered in-office, tDCS devices are small and battery powered, so ongoing clinical trials are established home-based tDCS treatments including trials for chronic pain, depression, Parkinson's and multiple sclerosis," he said.
One difference between the Fisher Wallace Stimulator and Soterix Medical's devices is the former has FDA clearance while Soterix is better known internationally.
"Soterix Medical is a New York City-based manufacturer of tDCS and will work with the FDA in clearance of tDCS for U.S. patients, including with ongoing support for clinical trials from the National Institutes of Health, including the National Institute of Drug Abuse," Bikson said.
Where a patient can access the more-portable TMS alternatives is an important consideration, Bikson said.
"The availability of local treatments may also vary depending on where a patient lives," he said. "For example, Soterix Medical tDCS is approved for the treatment for types of depression or pain across Europe, Canada, Australia, Brazil and many additional regions, but is not marketed as an on-label treatment in the United States. These international approvals are based on dozens of controlled clinical trials for tDCS, including for depression."
And some patients are still better off with more traditional TMS therapies, Roman said.
"I think the fact that a psychiatrist administers TMS can be valuable to a patient because the patient is getting that doctor's personal attention," he said. "I wish more people had access to highly trained psychiatrists. A lot of psychiatrists prescribe our device to patients. But the reality is, there are tens of millions of people in the United States who are never going to see a psychiatrist, let alone get TMS, either because of cost concerns, or geography, or a host of other reasons. Having a low-cost wearable option is critical to bring mental health care to a much larger percentage of the population."
