Outcomes of a Prospective, Multi-Center International Registry of DBS for Parkinson's Disease.

Introduction: The effectiveness and safety of the use of Deep Brain Stimulation (DBS) to reduce motor complications of subjects with Parkinson's disease (PD) has been substantiated by several randomized controlled trials (Deuschl et al., 2006, Weaver et al., 2009, Okun et al., 2012, Scheupbach et al., 2013). Motor improvement following DBS is sustained for up to 10 years as reported by Castrioto et al. An in-depth evaluation of real-world outcomes following DBS will add to the existing database of knowledge and prove to be a useful tool for physicians. We present the outcomes of a large scale clinical registry that compiles the effectiveness and safety-related real-world outcomes of a multiplesource, constant-current DBS System in the treatment of levodoparesponsive PD. Methods: The Vercise DBS Registry is a prospective, onlabel, multi-center, international registry sponsored by Boston Scientific Corporation. The Vercise DBS system (Boston Scientific) is a CE-marked, 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 where their overall improvement in quality of life and PD motor symptoms will be evaluated. Clinical endpoints will be evaluated at baseline and during study follow up that include Unified Parkinson's Disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson's disease Questionnaire (PDQ-39), and Global Impression of Change. The registry also utilizes the newly developed MDS UPDRS for the evaluation of motor symptoms and includes the evaluation of non-motor symptoms of PD (Non-Motor Symptom Assessment Scale) following DBS. Adverse events are also collected. Results: This report will provide the safety and effectiveness outcomes of the first cohort of subjects implanted with the Vercise DBS System analyzed at 6 months post-implantation as compared with baseline. Discussion: The Vercise DBS registry study represents the first comprehensive, large scale collection of real-world outcomes and evaluation of the safety and effectiveness of the Vercise DBS System. This report will provide such data from the first cohort of subjects analyzed at 6 months post-implantation as compared with baseline. [ABSTRACT FROM AUTHOR]