The results indicated that 38% of patients responded to the device whereas 11% of patients responded when using the sham device.
Carlos Pena, PhD, MS
The FDA has permitted marketing of the BrainsWay Deep Transcranial Magnetic Stimulation System for treatment of obsessive-compulsive disorder (OCD), according to BrainsWay Ltd.
The decision is backed by data from a randomized, multi-center 10-week phase III study of 100 participants, of which 49 participants received treatment with the BrainsWay device and 51 received treatment from a sham device.
“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” Carlos Peña, PhD, MS, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.1 “With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option.”
The study evaluated the safety and efficacy of the device in subjects 22—28 years old with OCD. The device technology is based on the application of deep brain transcranial magnetic stimulation by means of repetitive pulse trains at the predetermined frequency.
The treatment group received 5 weeks of daily treatments followed by 4 treatments in week 6, for a total of 29 treatment sessions, while the control group received the same treatments with a sham device.
The primary outcome of the study was to compare the change in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to week 6. Secondary outcomes included the YBOCS, Sheehan Disability Scale (SDS), Clinical Global Impression—Severity Scale (CGI-S), Clinical Global Impression–Improvement Scale (CGI-I), and secondary effectiveness objectives were the change from baseline to 6 weeks in the YBOCS, as well as other efficacy scales, the response rate at 6 weeks in YBOCS from baseline, partial response rate at 6 weeks in YBOCS score, change from baseline to 10 weeks in above scales, and remission rates at 6 weeks between treatment groups.
Additional outcome measures included the number of adverse effects, changes in vital signs, physical and neurological results, changes in suicide scale and changes in cognitive scales.
Results showed that after 6 weeks of treatment, there was a statistically significant improvement in YBOCS score for the active treatment group when compared to sham (P = .0157), 38% of participants responded to the BrainsWay device, whereas 11% of participants responded when treated with the sham device (P = .0033).2 Additionally, 54.8% of participants in the treatment group achieved a partial response, defined in the protocol, versus 26.7% in the sham group (P = .0076). The improved clinical effect in the YBOCS scores was maintained in the active group 1 month after treatment was finished, and the improvement was more distinct than that achieved in the sham group (P = .0459).
The most frequent adverse effect reported was headache by 37.5% of the BrainsWay device patient population vs. 35.3% of participants who received the sham treatment. No serious adverse effects related to the device were reported. Additional adverse reactions reported as mild or moderate and resolved after treatment were application site pain or discomfort, jaw pain, facial pain, muscle pain, spasm or twitching, and neck pain.
The device is contraindicated for those with metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes.
While being treated with the device, patients must use earplugs to reduce the exposure to loud sounds produced by the device. Health care providers should be informed of patients with a history of seizures prior to receiving the device.
The FDA was reviewed through the de novo premarket review pathway.
TMS has been approved as a treatment for major depression in 2008 and treating pain associated with certain migraine headaches in 2013.
1. FDA permits marketing of transcranial magnetic stimulation for treatment of
disorder [news release]. Silver Spring, Md.; August 17, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm617244.htm
2. Brainsway Announces Positive Final Results Of Its Deep-TMS Multicenter Study In Obsessive Compulsive Disorder (OCD) Patients [news release]. Jerusalem, Israel; June 12, 2017. https://www.brainsway.com/news_events/brainsway-announces-positive-final-results-deep-tms-multicenter-study-obsessive-compulsive-disorder-ocd-patients/