Abstract
Objective: To describe collected outcomes from a large-scale registry of a Deep Brain Stimulation (DBS) system capable of Multiple Independent Current Source Control (MICC) used for the management of symptoms of levodopa-responsive Parkinson’s disease (PD).
Background: The effectiveness of DBS for reducing motor complications of PD has been substantiated by randomized controlled trials (Schuepbach 2013). Additionally, motor improvement can be sustained for up to 10 years (Deuschl et al. 2013). Large patient data registries may facilitate insights regarding real world, clinical use of DBS. However, no registry database currently exists for a multiple-source, constant current DBS system.
Design/Methods: The Vercise DBS Registry (ClinicalTrials.gov Identifier: NCT02071134) is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific Corporation. The Vercise DBS system (Boston Scientific) is a multiple-source, constant-current system. Subjects were followed out to 3 years post-implantation where their overall improvement in quality of life and PD motor symptoms was evaluated. Clinical endpoints evaluated at baseline and during study follow included Unified Parkinson’s disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson’s disease Questionnaire (PDQ-39), and Global Impression of Change.
Results: To date, 360 patients have been enrolled in the registry and this report will provide an overview of data collected so far from implanted patients within this cohort. At 1 year post-implant, 35% improvement in MDS-UPDRS III scores (stim on/meds off) compared with baseline was reported. This improvement in motor function was supported by an improvement in quality of life as assessed by PDQ-39 Summary Index (4.7-point improvement, n =193) at 1 year. Roughly 90% of patients and clinicians reported improvement as compared with Baseline. New data collected out to 2 years post-implant will be reported.
Conclusions: This DBS registry represents the first comprehensive, large scale collection of real-world outcomes and evaluation of safety and effectiveness of a multiple-source, constant-current DBS system.
Disclosure: Dr. Deuschl has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Deuschl has received personal compensation in an editorial capacity for European Academy of Neurology. Dr. Deuschl has received royalty, license fees, or contractual rights payments from Thieme publisher and has received research support from Medtronic and Boston Scientific. Dr. Jain has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Wang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Scholtes has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities as an employee of Boston Scientific. Dr. Jain has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Vesper has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientiifc, Abbott. Dr. Vesper has received research support from Boston Scientific, Abbott.
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