Investigator:
Mallory Hacker, PhD
Name of Institution:
Vanderbilt University Medical Center, Nashville, Tennessee
Project Title:
Investigating Long-Term Clinical Outcomes of Subthalamic Nucleus Deep Brain Stimulation (DBS) in Early Stage Parkinson’s Disease (PD)
Investigator Bio:
Dr. Hacker earned her PhD in Cell & Developmental Biology at Vanderbilt University. She then received postdoctoral training in Neurology Clinical Research, also at Vanderbilt University. She is an Assistant Professor of Neurology at Vanderbilt University Medical Center. She was a Visiting Assistant Professor at the Bloomberg School of Public Health at Johns Hopkins University in 2016.
Objective:
The goal is to study 10-year changes in motor symptoms, medication burden, quality of life, dyskinesia, and cognition in patients who completed the DBS in early-stage PD pilot clinical trial.
Background:
A prospective, randomized, single-blind, pilot clinical trial was conducted at Vanderbilt University from 2006-2014, and this trial was the first investigation into the safety and tolerability of DBS in early-stage PD (IDE G050016, NCT 0282152, IRB 040797). Since joining the pilot as early-stage patients, this PD cohort has now progressed 10 years to a stage where quality of life is typically adversely affected by motor and cognitive symptoms that are increasingly resistant to medications. This proposal will be the first to address questions concerning DBS’s durability as a potential long-term therapy when applied during early-stage PD.
Methods/Design:
A longitudinal follow-up visit will be conducted in patients who completed the only prospective, randomized, controlled pilot clinical trial of DBS in early-stage PD. Subjects will be evaluated at the Vanderbilt Clinical Research Center following the same protocol that was implemented for the pilot study. United Parkinson’s Disease Rating Scale motor examination videos will be scored in a randomized, blinded fashion by the same independent rater who evaluated videos for all prior pilot trial study visits.
Relevance to Diagnosis/Treatment of Parkinson’s disease:
Completion of this research will fill a gap in the field by providing the first report of longitudinal clinical outcomes following DBS in early stage PD. Importantly, this project will collect the first 10-year results from a prospective, randomized, controlled trial of DBS at any stage of PD. These data will also further inform the design of the FDA-approved pivotal trial of DBS in early-stage PD (IDE G050016) and also generate new hypotheses to be tested in sub-studies within the pivotal trial and in future investigations.