FDA gives go ahead to system designed to treat Obsessive Compulsive Disorder
August 18, 2018
(NATIONAL) – On Friday the U.S. Food and Drug Administration gave the okay for the marketing of a system called Brainsway Deep Transcranial Magnetic Stimulation for the treatment of obsessive compulsive disorder (OCD).
The FDA permitted marketing of the Brainsway device to Brainway Ltd.
“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” said Carlos Peña, Ph.D., M.S., 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.”
OCD is a common, chronic and long-lasting disorder in which a person has uncontrollable, reoccurring thoughts and behaviors that a person feels the urge to repeat over and over.
OCD is typically treated with medication, psychotherapy or a combination of the two. 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.
Transcranial magnetic stimulation (TMS) is a procedure that uses magnetic fields to stimulate nerve cells in the brain. The FDA permitted marketing of TMS as a treatment for major depression in 2008 and expanded the use to include TMS for treating pain associated with certain migraine headaches in 2013.
The FDA reviewed data from a randomized, multi-center study of 100 patients, of which 49 patients received treatment with the Brainsway device and 51 received treatment with a non-working (sham) device.
The results indicated that 38 percent of patients responded to the Brainsway device whereas 11 percent of patients responded when using the sham device.