VCU news

By Sathya Achia Abraham

The Virginia Commonwealth University Medical Center is one of approximately 20 institutions taking part in a national clinical trial evaluating a medical device that provides focused stimulation to the brain that may offer an effective therapy for people with severe depression.

The first two patients in the VCU portion of the study underwent implantation of the deep brain stimulator for the treatment of depression last month at the VCU Medical Center.

The BROdmann Area 25 DEep brain Neuromodulation study, or BROADEN™ study, is the first randomized clinical research study to investigate the use of deep brain stimulation as an intervention for people with major depression. The clinical study will involve patients diagnosed with unipolar major depressive disorder, excluding bipolar disorder, who have failed at least four treatment options in their current episode.

Deep brain stimulation, which has been used since 1997 to treat movement disorders and Parkinson’s disease, is a therapy that uses mild pulses of current, or stimulation, to regulate specific areas of the brain much like a pacemaker uses pulses of current to regulate the heart.

VCU was chosen to participate in this clinical trial because of its expertise in treating patients with psychiatric illness and use of various forms of neuromodulation therapies in which pulses of current or magnetic fields are used to alter brain activity to help relieve symptoms of depression and other conditions.

“A technology such as this has the potential to deeply impact the lives of patients with severe depression and their families,” said Ananda Pandurangi, M.D., professor and vice chair of psychiatry at the VCU Medical Center, who will be leading the study at the VCU site together with Kathryn Holloway, M.D., professor in the VCU Department of Neurosurgery.

In this study, stimulation will be delivered to an area of the brain believed to function differently in people with major depression and appears to be overactive when people are profoundly sad and depressed. The BROADEN study builds on the work of a research team from the University of Toronto, led by Helen S. Mayberg, M.D., and Andres Lozano, M.D.

The VCU Department of Psychiatry currently offers several types of neuromodulation therapies including electroconvulsive therapy, which has been used as an effective treatment for severe depression since the 1930s; repetitive transcranial magnetic stimulation, which was approved by the FDA in 2008 for the treatment of major depression that has failed to improve after one treatment course; vagus nerve stimulation, which was FDA-approved in 2005 for the treatment of chronic or recurrent major depression and which uses pulses of current to stimulate centers in the brain that regulate mood, sleep, appetite, and motivation; and DBS, which is currently used for treating Parkinson’s disease, other movement disorders, and severe cases of obsessive compulsive disorder.

The study is sponsored by St. Jude Medical under a U.S. Food and Drug Administration investigational device exemption (IDE).

For more information about the BROADEN study, call 877-796-8732 or visit www.BroadenStudy.com, or contact Megan Edwards, VCU Deep Brain Stimulation Study Coordinator at (804) 828-4570 or mcedwards@vcu.edu.