FDA Approves Brain Stimulation Device for OCD
FRIDAY, Aug. 17, 2018 -- A brain stimulation device to treat obsessive-compulsive disorder (OCD) has received approval for marketing Friday by the U.S. Food and Drug Administration.
Transcranial magnetic stimulation uses magnetic fields to stimulate nerve cells in the brain. The FDA approved it as a treatment for major depression in 2008 and for treating pain associated with certain migraines in 2013.
"Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches," said Carlos Pena, director of the division of neurological and physical medicine devices at 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," Pena added in an agency news release.
The approval of the Brainsway Deep Transcranial Magnetic Stimulation System was based on a study of 100 OCD patients. Thirty-eight percent of those treated with the device had a more than 30 percent reduction in the severity of their symptoms, compared with 11 percent of those treated with a non-working ("sham") device.
No serious reactions to treatment with the device were reported, according to the FDA.
People with OCD have uncontrollable, reoccurring thoughts and behaviors. About 1 percent of U.S. adults had OCD in the past year, according to the U.S. National Institute of Mental Health. The disorder is typically treated with medication, psychotherapy or both. Most patients respond to treatment, but some continue to have symptoms.
The U.S. National Institute of Mental Health has more on OCD.
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Posted: August 2018