The Michael J. Fox Foundation for Parkinson's Research

The Michael J. Fox Foundation for Parkinson's Research is using its 2018 distribution to fund:

Registry for the Advancement of DBS in Parkinson’s Disease (RAD-PD)

PROJECT TITLE: Registry for the Advancement of DBS in Parkinson’s Disease (RAD-PD)

Investigator/Author: Joohi Jimenez-Shahed, MD and Jim McInerney, MD

Objective: This project will identify the best practices surrounding DBS therapy, identify the adverse effects (and determinants) of DBS therapy, and identify the health economics and disparities related to DBS therapy, thereby helping clinicians identify ways to improve DBS treatment processes and patient outcomes.

Background: Many clinical questions about DBS therapy cannot be practically answered through traditional clinical trials methodology.  RAD-PD will be conducted as a quality improvement project, a form of health effectiveness research that is focused on measuring and monitoring outcomes in order to secure positive change.

Methods/Design: This study has 2 phases.  In the first phase, we will use an neuroimaging method called positron emission tomography and gradually escalating doses of varenicline to find the most appropriate dose for Parkinson disease patients.  In the second phase, we will administer the selected dose of varenicline to Parkinson disease patients in a double-blind crossover trial. Laboratory measures of gait and balance will be obtained on and off varenicline.  This will allow us to determine if varenicline, or similar drugs, should be pursued as treatments for Parkinson disease.  

Relevance to Diagnosis/Treatment of Parkinson’s Disease: Relevance to Diagnosis/Treatment of Parkinson’s disease: The quality improvement design of this patient registry will generate large datasets that can provide insights into treatment patterns and related outcomes for DBS. Analysis of registry data will allow investigators to fill knowledge gaps in the current evidence base about DBS in PD, provide information that is applicable within a spectrum of clinical care environments, and yield recommendations for practice improvement that will enhance therapy outcomes for patients with Parkinson’s disease.

September 2019 Project Update:

The study officially launched in April 2019 and 9 out of 10 study sites identified for Year 1 data collection are now fully activated. Screening and registry enrollment of potential research participants is ongoing at the activated sites. We anticipate by end of year we will have a more robust update to share preliminary insights into pre-operative considerations.

November 2020 Project Update:

Baseline data from the first study participants enrolled shows considerable heterogeneity in patient characteristics which will form the basis of ongoing quality improvement analyses. Ongoing subject enrollment was significantly delayed by COVID-19 shutdowns and a need to redesign the study’s data management platform necessary to meet the registry goals. Additional sites are now undergoing activation and training procedures for continued enrollment.