FDA Allows Brain Implants for Obsessions
Once the electrodes are implanted, clinicians can control how electrical pulses are delivered to the brain using a battery-run, pacemaker-like device outside the body. By trial and error, doctors figure out what patterns of electrical activity are most likely to help patients while producing the fewest side effects.
OCD is a condition that prompts people to have debilitating and recurring thoughts and compulsive behaviors, such as hand-washing. It is an anxiety disorder, and the FDA approval suggests officials believe that deep brain stimulation might help reduce anxiety. The device was approved for use when conventional treatments, such as medications and talk therapy, have not worked.
The FDA action was designated a “humanitarian device exemption,” a regulatory mechanism designed to encourage the development of treatments for disorders that affect fewer than 4,000 people in the United States. Manufacturers do not have to prove that the device helps patients, only that it can be used safely and is likely to be effective. The FDA said it based its decision on a small study that found deep brain stimulation improved the condition of 26 patients with persistent obsessive-compulsive disorder by an average of 40 percent.
The device approved by the FDA is called Reclaim and is manufactured by Medtronic Inc. of Minneapolis.
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