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Abstract Details

Outcomes of a Prospective, Multicenter, International Registry of Deep Brain Stimulation for Parkinson's Disease
Movement Disorders
P1 - Poster Session 1 (5:30 PM-6:30 PM)
10-039
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). 
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.

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. 
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. 

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. 
Authors/Disclosures
Guenther Deuschl, MD, FAAN (Dept. of Neurology, Christain-Albrechts Univ)
PRESENTER 		Dr. Deuschl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Dr. Deuschl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific Cavion Functional Neuromodulation. The institution of Dr. Deuschl has received research support from Medtronic. Dr. Deuschl has received publishing royalties from a publication relating to health care.
Roshini Jain Roshini Jain has received personal compensation for serving as an employee of Boston Scientific. Roshini Jain has received stock or an ownership interest from Boston Scientific.
No disclosure on file
No disclosure on file
Roshini Jain Roshini Jain has received personal compensation for serving as an employee of Boston Scientific. Roshini Jain has received stock or an ownership interest from Boston Scientific.
No disclosure on file