The Brainsway Deep Transcranial Magnetic Stimulation (TMS) System can be marketed as a treatment for obsessive compulsive disorder (OCD), the US Food and Drug Administration (FDA) announced.
“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” said Carlos Peña, PhD, MS, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option.”
The authorization comes after a multicenter study of 100 patients randomized to treatment with the Brainsway device or a sham device. Among the treatment group, 38% of patients had a greater than 30% reduction in their score on the Yale-Brown Obsessive Compulsive Scale, compared with 11% of the patients using the sham device. Patients receiving other OCD treatments continued them throughout the study.
The most common adverse event was headache, reported by 37.5% of the treatment group and 35.3% of patients who received the sham treatment. Other adverse reactions—including application site pain or discomfort, jaw pain, facial pain, muscle pain, spasm and twitching, and neck pain—were described as either mild or moderate and resolved shortly after treatment. No patients reported serious adverse events related to the Brainsway device.
The FDA approved marketing TMS as a treatment for major depression in 2008 and as a treatment for pain associated with certain migraine headaches in 2013. It has been studied as a potential treatment for several other psychiatric and neurologic disease states.