The FDA has announced that it will permit marketing of the Brainsway Deep Transcranial Magnetic Stimulation System for the treatment of obsessive compulsive disorder (OCD).
According to the National Institute of Mental Health, about 1 percent of U.S. adults had OCD in the past year. Although most patients with OCD respond to treatment, some patients continue to experience symptoms.
The FDA permitted marketing of transcranial magnetic stimulation (TMS) as a treatment for major depression in 2008 and expanded its use to treat pain associated with certain migraine headaches in 2013.
The FDA reviewed data from a randomized, multi-center study of 100 patients, 49 of whom received treatment with the Brainsway device; 51 patients received treatment with a sham device. Patients already receiving OCD treatments (medical management) were maintained at their current dosages throughout the study. The study evaluated the reduction in patients’ Yale-Brown Obsessive Compulsive Scale (YBOCS) score, a common metric for measuring the severity of a patient’s OCD. The results indicated that 38 percent of patients responded to the Brainsway device (i.e., greater than 30 percent reduction in YBOCS score), whereas 11 percent of patients responded when using the sham device.
The most frequent adverse reaction was headache, which was reported by 37.5 percent of the patients who received the Brainsway device and by 35.3 percent of the patients who received the sham treatment. No serious adverse reactions related to the Brainsway device were reported. Other adverse reactions, such as application-site pain or discomfort, jaw pain, facial pain, muscle pain, spasm or twitching, and neck pain, were reported as either mild or moderate and resolved shortly after treatment.
Source: FDA.gov, August 17, 2018