Medtronic’s Reclaim Deep Brain Stimulation Therapy became the first deep brain stimulation device approved by the FDA to treat a psychiatric condition.
Medtronic’s Reclaim Deep Brain Stimulation Therapy yesterday became the first deep brain stimulation (DBS) device approved by the FDA to treat a psychiatric condition when it received a humanitarian device exemption (HDE) for the treatment of chronic, severe obsessive-compulsive disorder (OCD). Medtronic anticipates that “DBS therapy will be appropriate for a small subset of the patient population, below the threshold of 4,000 patients per year allowed under an HDE.”
"In the most severe cases, OCD causes profound impairment in work and social life, as well as tremendous suffering," said Benjamin D. Greenberg, MD, PhD, associate professor of psychiatry, Butler Hospital and the Alpert Medical School of Brown University, the principal investigator in a new trial of DBS for OCD. "Our work, plus that of colleagues in Europe, shows that DBS is a promising treatment for a subset of patients with OCD who have remained very ill and debilitated despite aggressive use of medications and cognitive behavioral therapy."
Agreeing with Greenberg, Ali Rezai, MD, neurosurgeon, Cleveland Clinc, said “For patients with OCD, DBS therapy represents an alternative therapeutic approach, which may be an option for patients who did not experience a benefit from more traditional treatments."
Combined long-term results of studies looking at DBS for OCD found clinically meaningful symptom reductions and functional improvement in nearly two-thirds of 26 patients with severe, treatment-resistant OCD, with a majority of the patients moving from severe ratings to mild or moderate ratings at various post-implantation follow-up times. In 42% of study participants, 15 of 23 serious adverse events were resolved without sequelea. Learn more at www.medtronic.com/ocd.
A new study has just begun at several locations across the country, looking at the device to treat treatment-resistant depression. "The clinical trial of DBS in treatment-resistant depression is an important step in understanding this therapeutic approach for patients with severe depression," said Rezai. Learn more about this study at http://www.clinicaltrials.gov/ct2/show/NCT00837486?. "This patient population is so severely impacted by their disease that they struggle to engage in social activities or even daily tasks," said Donald Malone, MD, psychiatrist, Cleveland Clinic and co-lead investigator in the trial. "This clinical trial is an important step forward in evaluating this therapy in a severely depressed patient population where currently available treatments have not provided relief."