Abstract Details

Title Outcomes of a Prospective, Multicenter, International Registry of Deep Brain Stimulation for Parkinson's Disease

Topic Movement Disorders

Presentation(s) P1 - Poster Session 1 (12:00 PM-1:00 PM)

Poster/Presentation
Number 3-002

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) in 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 et al., 2013). Additionally, motor improvement is sustained for up to 10 years (Deuschl et al. 2013). Large patient data registries may facilitate insights regarding real world, clinical use of DBS. Furthermore, no registry database currently exists for a multiple-source, constant current DBS system.

Design/Methods

The Vercise DBS Registry is a prospective, on-label, multi-center, global registry sponsored by Boston Scientific Corporation. The Vercise DBS system (Boston Scientific) is a multiple-source, constant-current system. Subjects were followed up to 3 years post-implantation and their overall improvement in quality of life and motor symptoms was evaluated. Clinical endpoints included Unified Parkinson's disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson's disease Questionnaire (PDQ-39), non-motor symptom assessment (NMSS) and Global Impression of Change.

Results To date, 465 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, 34% 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 PDQ39 Summary Index (4.2-point improvement, n=237) 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. Additionally, data related to non-motor symptoms will also be presented.

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.

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
Michael Barbe	No disclosure on file
Steffen Paschen	The institution of Steffen Paschen has received research support from Deutsche Forschungsgemeinschaft. The institution of Steffen Paschen has received research support from Parkinsonfonds. The institution of Steffen Paschen has received research support from UCB .
Andrea Kuehn	Andrea Kuehn has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Andrea Kuehn has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Boston Scientific.
Jens Volkmann, MD (University Hospital of Wuerzburg)	Jens Volkmann, MD has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ceregate. Jens Volkmann, MD has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Newronika. Jens Volkmann, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Boston Scientific. Jens Volkmann, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. Jens Volkmann, MD has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bial. Jens Volkmann, MD has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbott. The institution of Jens Volkmann, MD has received research support from DFG. The institution of Jens Volkmann, MD has received research support from BMBF. The institution of Jens Volkmann, MD has received research support from Boston Scientific. The institution of Jens Volkmann, MD has received research support from Medtronic.
	No disclosure on file
	No disclosure on file