A decade after taking part in the first clinical trial of deep brain stimulation (DBS) administered during very early-stage Parkinson’s disease, participants will return to Vanderbilt University Medical Center this year to be re-evaluated.
This longitudinal study is made possible by a $275,000 grant to Mallory Hacker, PhD, research assistant professor of Neurology, from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the National Institutes of Health (NIH).
The research has also received $50,000 in support from the American Parkinson Disease Association (APDA).
These funds will allow researchers to collect long-term outcomes on this unique cohort who joined the original trial 10 years ago.
“This work will provide valuable longitudinal information to the Parkinson’s disease community from the only prospectively-followed group of patients to receive DBS in the earliest stages of the disease,” Hacker said.
Hacker was the lead author of an article published recently in Neurology reporting an analysis from the original trial that suggests early DBS might slow the progression of rest tremor. That report is significant because it is the first evidence of a treatment that may possibly delay the progression of one of the cardinal features of Parkinson’s disease.
David Charles, MD, professor and vice-chair of Neurology, the article’s senior author, led the clinical trial at Vanderbilt in which patients were recruited between 2006 and 2009.
“The investment by the NIH and APDA signals the importance of this line of research as we seek to understand the long-term impact of DBS when applied in very early stage Parkinson’s disease,” Charles said. “This study will be the longest follow-up of any prospective, controlled trial of DBS for Parkinson’s disease.”
Charles’ pilot trial randomized 30 early-stage patients, half of whom underwent DBS surgery in addition to medications, with the other half receiving just medications. Charles has at this point contacted 17 of those patients who have agreed to undergo a week of tests at the VUMC Clinical Research Center.
The protocols for the testing will be the same as they were in the original trial, including a washout of all Parkinson’s disease therapies, conducted to evaluate underlying disease progression. Additionally, there will be one new assessment included in the follow-up study.
“The NINDS grant provides funding to incorporate FDG-PET scans at this 10-year evaluation,” Hacker said. “These images will provide preliminary data to help understand how long-term, early application of DBS therapy influences Parkinson’s disease-related metabolic brain networks.”
The U.S. Food and Drug Administration has approved VUMC to lead the next early DBS trial, a large-scale, Phase III multicenter study that will enroll 280 people with very early-stage Parkinson’s disease. Seventeen other U.S. medical centers have agreed to participate in that pivotal trial and joined the DBS in Early Stage Parkinson’s Disease Study Group. The launch of that study is expected to begin in 2019. VUMC is one of the world’s top DBS centers, where a multidisciplinary team has provided the therapy to more than 1,000 patients.
