Vercise DBS Registry: A Prospective, Multi-center International Registry for Parkinson’s Disease (P1.171)

OBJECTIVE: The Vercise DBS Registry compiles the effectiveness and safety-related outcomes of Boston Scientific Corporation’s commercially approved Vercise System for Deep Brain Stimulation (DBS) in the treatment of levodopa-responsive Parkinson’s disease (PD). BACKGROUND: In the 1990s, high-frequency deep brain stimulation (DBS) was demonstrated to be effective in reducing the motor complications of subjects with PD (Limousin, et al . 1995). Since that time, several randomized controlled trials and reviews have substantiated these early findings (Deuschl et al. 2006, Weaver et al . 2009, Williams et al . 2010, Okun et al . 2012, Scheupbach et al . 2013). Motor improvement following DBS has also shown to be sustained up to 10 years (Castrioto et al . 2011) METHODS: Vercise DBS Registry is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific Corporation. Vercise DBS is a multiple-source, constant-current system with a rechargeable battery. Subjects will be followed up at 3, 6, 12 months and up to 3 years post-implantation. Subject’s overall improvement in quality of life and their PD motor symptoms will be evaluated up to 3 years post-implantation. Assessments including Unified Parkinson’s disease Rating Scale (UPDRS), new UPDRS scale - MDS-UPDRS Parkinson’s disease Questionnaire (PDQ-39), and Global Impression of change will be administered at Baseline and during study follow up. Clinical endpoints will evaluate changes in PDQ-39 scores, UDPRS or MDS-UPDRS, and antiparkinsonian medication usage during study follow up as compared with baseline. Adverse events are collected. RESULTS: The accompanying report provides the study design, demographics, programming parameters, and other preliminary data from Vercise DBS Registry. CONCLUSIONS: The Vercise DBS registry collects real-world outcomes of the use of Vercise DBS System in the treatment of Parkinson’s disease including safety and effectiveness. Additionally, programming parameters and the economic value of DBS will also be evaluated. Study Supported by: Boston Scientific Corporation Disclosure: Dr. Deuschl has nothing to disclose. Dr. Vesper has nothing to disclose. Dr. Lin has received personal compensation for activities with Boston Scientific Corporation as an employee. Dr. Van Dyck has received personal compensation for activities with Boston Scientific Corporation as an employee. Dr. Jain has received personal compensation for activities with Boston Scientific Corporation as an employee.