FRIDAY, Aug. 17, 2018 — The Brainsway Deep Transcranial Magnetic Stimulation System has been approved by the U.S. Food and Drug Administration to treat obsessive compulsive disorder (OCD).
OCD is a chronic condition characterized by uncontrollable, recurring thoughts and actions that a person feels the need to continually repeat. Government statistics show about 1 percent of people in the United States had OCD in the past year, the FDA said Friday in a news release.
The condition typically has been treated with medication, psychotherapy or a combination of both.
“With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option,” said Carlos Peña, Ph.D., director of the FDA’s Division of Neurological and Physical Medicine Devices.
Transcranial magnetic stimulation (TMS) uses magnetic fields to stimulate the brain’s nerve cells. The procedure was approved in 2008 to treat major depression and in 2013 to treat certain migraines, the FDA said.
To evaluate the procedure’s performance for OCD, the agency said it reviewed a clinical study involving 100 people, of whom 49 were treated with the actual device and 51 were treated with a non-working model. Some 38 percent of people treated with the Brainsway device responded positively, versus 11 of people treated with the sham device.
The most common adverse reactions from the Brainsway device included headache, jaw pain, facial pain, muscle pain, spasms and twitching, the FDA said. No serious adverse reactions were reported.
The device shouldn’t be used by people who have had metal devices, stimulating devices or stents implanted. People shouldn’t wear jewelry or hair barrettes while being treated, the FDA said.
The device is produced by the Israeli firm Brainsway Ltd.
Visit the FDA to learn more.
Posted: August 2018
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