FDA approves deep brain stimulation device

FDA approves deep brain stimulation device
(May 2009 Issue)

By Ami Albernaz

The Food and Drug Administration has approved the first implantable device for people with severe obsessive-compulsive disorder, offering hope to a small percentage of people with the illness. Medtronic Inc.'s Reclaim DBS (deep brain stimulation) Therapy is expected to become available in the middle of this year.

The device was approved in February under the FDA's humanitarian-device exemptions rules, and will be used on fewer than 4,000 patients annually. In a study leading up to the approval, about two-thirds of 26 patients with severe OCD saw their symptoms improve with the device.

Darin Dougherty, M.D., director of the Division of Neurotherapeutics at Massachusetts General Hospital's Department of Psychiatry, calls the Reclaim approval "a pretty exciting development."

"It will always be for a very small subset of patients," he says. "But to have half or more respond is great."

The pacemaker-like device is implanted in the chest and connected to four electrodes in the brain. Unlike stimulation devices developed for Parkinson's disease, the Reclaim stimulator targets areas linked to mood and anxiety. Forty-two percent of patients in the trial saw adverse effects such as changes in mood or anxiety, but most were resolved following adjustments with the device.

"It's not without risk, because it's a craniotomy," Dougherty says. The risk profile is similar to cases in which DBS is used to treat Parkinson's disease, he adds.

The Reclaim device is not purported to be a cure for OCD. Patients receiving the implant will likely continue taking medication as well.

Medtronic is currently studying a deep brain stimulation device for severe depression.

Jeff Szymanski, Ph.D., executive director of the Boston-based Obsessive Compulsive Foundation, says there might someday be less intrusive options for those suffering from severe OCD. He points to studies that have suggested links between glutamate levels and OCD, though research on glutamate-affecting drugs and OCD has so far been inconclusive.

Controlled, double-blind studies of one such drug in adults and children with OCD are now under way, though it will likely be a few years before results are known.