McGowan Institute for Regenerative Medicine
faculty member Douglas Kondziolka, MD (pictured), the Peter J. Jannetta Professor and vice chairman of education in Neurological Surgery, professor of Radiation Oncology, and director of the Center for Image-Guided Neurosurgery, and UPMC psychiatrist Robert Howland lead a team of scientists and clinicians who are part of an investigational study of the Reclaim™ Deep Brain Stimulation (DBS) System in people that have treatment-resistant depression. Dr. Kondziolka has done the DBS surgery on 4 patients, with a fifth scheduled soon, as part of a multicenter trial of the procedure in about 30 depressed patients. Half of them will have their devices turned on for 4 months while the other half will not have theirs turned on until after that period. UPMC is one of five hospitals involved in the study nationwide.
The trial is designed to test whether the procedure is safe and has a measurable benefit for those whose devices are activated. If the federal Food and Drug Administration approves, the experiment, using equipment manufactured by Medtronic, Inc., will be expanded to hundreds of patients nationally, Dr. Kondziolka said.
The experimental DBS surgery operates on the premise that a small, steady voltage applied to the electrodes can quiet the "sadness center" that is hyperactive in people with chronic depression. Participants implanted with the device systems will be monitored for 12 months following implant, with long-term follow-up until the device is approved or the study is stopped.
Even though the electrodes are providing extra current to small zones in the brain, it seems that they are actually dampening or evening out brain activity in those areas.
"In some of the depression studies that have been done, they have found these cells are overactive," Dr. Kondziolka said, "and it's thought that the DBS is calming them down, preventing them from firing."
The DBS equipment has a proven track record. It has been used on more than 30,000 American patients with Parkinson's disease or other movement disorders, quieting areas in their brains that cause the tremors, rigidity, and jerking that are part of those conditions.
DBS is being tried on people with two other disorders: Tourette syndrome, which causes involuntary movements and vocalizations; and obsessive-compulsive disorder, or OCD, which leads to anxious, repetitive behaviors like hand washing or constantly checking whether doors are locked.
There has even been some early work on using DBS for people with morbid obesity, threading the electrodes into the part of the hypothalamus that helps control appetite.
Candidates for the trial are adults who have major depressive disorder and have not responded to several treatments for depression. Participants in the study will continue to receive their current antidepressant medications while participating in the trial.
DBS therapy is currently approved for use in the United States, Europe, Canada, and Australia for the treatment of Essential Tremor and Parkinson's disease. Deep brain stimulation for the treatment of depression is investigational.
Depression is a mood disorder and a serious medical condition that affects millions of Americans. Depressive symptoms may include loss of interest in things typically enjoyed; decreased energy levels; difficulty concentrating or making decisions; restlessness; and feelings of pessimism, hopelessness, and worthlessness. Treatment-resistant depression is a chronic and severe form of depression characterized by failure to respond to traditional forms of treatment, such as antidepressant medications and electroconvulsive therapy. Treatment-resistant depression significantly impacts quality of life, productivity, and is a major contributor of disability world-wide.
Illustration: McGowan Institute for Regenerative Medicine.
Pittsburgh Post-Gazette (01/17/10)
Clinical Trial: Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression
Bio: Dr. Douglas Kondziolka