Transcranial magnetic stimulation cleared for OCD.
The Food and Drug Administration has cleared the way for marketing of the Brains Way deep transcranial magnetic stimulation system for treating patients with treatment-resistant obsessive-compulsive disorder (OCD).
"With today's marketing authorization, patients with OCD who have not responded to traditional treatments now have another option," said Carlos Pena, PhD, director of the division of neurological and physical medicine devices in the FDA's Center for Devices and Radiological Health, in an Aug. 17 news release.
The clearance is based on results of a randomized, multicenter study of 100 patients, 49 of whom were treated with the BrainsWay device and 51 of whom with a sham device. Of the patients treated with the BrainsWay device, 38% had a 30% or greater reduction in their Yale-Brown Obsessive Compulsive Scale scores, which measures severity of OCD symptoms, whereas only 11% treated with the sham device experienced such a reduction.
The most common adverse reaction was headache, which was experienced by 37.5% of patients treated with the BrainsWay device and 35.0% of those treated with the sham device. No serious adverse events were reported.
Other common reactions included application site pain or discomfort, spasm or twitching, and jaw, facial, muscle, or neck pain; all of those were reported as mild or moderate and resolved quickly after each treatment was completed.
The device is contraindicated in patients with any sort of metal in or near their heads, such as cochlear implants or vagus nerve stimulators. Patients with a history of seizure who are interested in using the device should first discuss the possibility with their health care clinician.
Transcranial magnetic stimulation was approved for the treatment of major depressive disorder in 2008 and for pain tied to migraine with aura in 2013.
The device will be marketed by Brainsway.
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|Title Annotation:||FDA NEWS; obsessive-compulsive disorder|
|Publication:||Clinical Psychiatry News|
|Article Type:||Brief article|
|Date:||Sep 1, 2018|
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