FDA Clears Transcranial Magnetic Stimulation for OCD

FDA has granted Brainsway de novo marketing clearance for its Deep Transcranial Magnetic Stimulation System for treating obsessive compulsive disorder (OCD). The device uses magnetic fields to stimulate nerve cells in the brain. It was originally cleared in 2008 for treating major depression, and in 2013 it was cleared for certain migraine headaches.

To permit the OCD indication, FDA reviewed data from a randomized, multi-center study of 100 patients, of whom 49 received treatment with the Brainsway device and 51 received treatment with a sham device. “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,” an agency release says. “The results indicated that 38% of patients responded to the Brainsway device (i.e., greater than 30% reduction in YBOCS score), whereas 11% of patients responded when using the sham device.”