(PSYCHIATRIC TIMES) - Psychiatrists will have to take the lead in ensuring that deep-brain stimulation (DBS)—approved by the FDA in February for the first time for use in obsessive-compulsive disorder (OCD)—is used appropriately.
Medtronic Inc’s Reclaim DBS therapy was approved under a humanitarian device exemption, which means that the system will be used on a relatively small number of adults (no more than 4000 and probably considerably fewer) with recalcitrant OCD.
The DBS device offers an adjustable, reversible, and nondrug therapy. This surgically implanted device- similar to a pacemaker- delivers carefully controlled electrical pulses to precisely targeted areas of the brain.
Only one other medical device has been approved for treatment of a psychiatric condition: the vagus nerve stimulation (VNS) implantation device made by Cyberonics. In 1997, the FDA approved the use of VNS as an adjunctive therapy for partialonset epilepsy; in 2005, its use in treatment-resistant depression was also approved. But Benjamin D. Greenberg, MD, PhD, told Psychiatric Times that VNS has been somewhat controversial, and insurance reimbursement remains an issue. Greenberg, who is associate professor of psychiatry at Brown University Medical School in Providence, RI, noted, however, that VNS does not involve brain surgery, as DBS does. Thus, the potential adverse effects from DBS, while relatively rare, can be more serious.
Greenberg is associated with Butler Hospital in Providence, where part of the Medtronic pilot study that paved the way for FDA approval took place. Greenberg was the lead US investigator in a pilot study of 26 patients; that study was funded by Medtronic and the National Alliance for Research on Schizophrenia and Depression. Dr Greenberg has received honoraria from Medtronic for consulting and speaking in addition to research funding.
Medtronic’s DBS device has been used in this country since the early part of this decade. But only a few academic medical centers are qualified to combine the type of psychiatry and neurosurgery that results in successful outcomes, which includes minimizing adverse reactions, according to Greenberg. Greenberg estimated that OCD is resistant to conventional treatment approaches in fewer than 5% of patients.
“Deep brain stimulation using the Reclaim system may provide some relief to certain patients with severe obsessive-compulsive disorder who have not responded to conventional therapy,” said Daniel Schultz, MD, director of the FDA Center for Devices and Radiological Health.
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