A consortium led by Vanderbilt University Medical Center (VUMC) researchers has received funding as it makes plans for a multicenter trial that could determine whether deep brain stimulation (DBS) slows the progression of Parkinson's disease in early-stage patients.
A grant from the Parkinson's Disease Foundation and the American Parkinson's Disease Association supporting the Disease Modification in Early Parkinson's Disease Consortium has been matched by Phyllis, Tony and Elizabeth Heard.
The trial has also received planning grant support from The Michael J. Fox Foundation for Parkinson's Research.
Mallory Hacker, Ph.D., assistant professor of Neurology, serves as executive director of the DBS in Early Stage Parkinson's Disease Study Group, which includes VUMC and 17 other U.S. medical centers.
The group is preparing to launch a Phase 3 study that has been approved by the U.S. Food and Drug Administration. Currently, DBS is approved to help control symptoms in patients with mid-stage to advanced-stage disease. The study could potentially provide the evidence required by the FDA to change the labeling for the medical device used in DBS to include early-stage Parkinson's disease. Currently, there is no therapy that is proven to stop, reverse or even slow the progression of Parkinson's disease.
"Our team's overarching goal is to determine if very early DBS will dramatically slow the progression of Parkinson's disease," said David Charles, M.D., chief medical officer of the Vanderbilt Neuroscience Institute. "If that were proven true, it would be a landmark achievement in the battle against this devastating disease."
The FDA approved the multicenter trial after VUMC researchers published results of a study in 2012 of 30 people with early-stage Parkinson's who were receiving DBS plus optimal drug therapy (ODT) or ODT alone.
Last year, the VUMC team published an updated report of the patients enrolled in that trial. They concluded that DBS in early-stage Parkinson's may reduce the risk of clinically important worsening by 50 to 80 percent after two years.