Abstract Details

Title Real-World Outcomes Using a Novel Directional DBS System for Parkinson's disease

Topic Movement Disorders

Presentation(s) P2 - Poster Session 2 (11:45 AM-12:45 PM)

Poster/Presentation
Number 5-001

Objective In this report, initial real-world outcomes using a directional lead with a Deep Brain Stimulation (DBS) system capable of multiple independent current source control (MICC) for use in managing symptoms of levodopa-responsive Parkinson's disease (PD) are reported.

Background Early Deep Brain Stimulation (DBS) systems used ring-shaped electrodes to achieve axial selectivity in stimulation of target tissue. However, directional current steering allows for rotational selectivity (in addition to axial) and has potential to further improve patient outcomes by avoiding off-target stimulation due to the ability to create a well-defined field around the intended target. Several pilot studies have corroborated use of directionality and its impact on therapeutic window and adverse effects.

Design/Methods The Vercise DBS Registry (ClinicalTrials.gov Identifier: NCT02071134) is a prospective, on-label, multi-center, international registry. Subjects were implanted with a directional lead included as part of a multiple source, constant current directional DBS system (Vercise Cartesia, Boston Scientific). Subjects were followed up 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-up included Unified Parkinson's disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson's disease Questionnaire (PDQ-39), and Global Impression of Change.

Results To date, 627 patients implanted with a directional DBS System have been evaluated. Improvement in quality of life as assessed by PDQ-39 (p < 0.001) up to 1-year demonstrated clinically significant improvement (minimal clinically important difference [MCID]: 4.7-points). Out to 2-years, improvement was sustained despite expected 5-point worsening due to disease progression. Improvements in motor function (change in MDS-UPDRS III scores meds-off condition) versus baseline were also noted (31% at 1-year; n=200, p<0.001).

Conclusions This on-going registry represents the first comprehensive, large scale collection of real-world, long-term outcomes using a directional lead and an MICC-based 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 .
Chong S. Lee, MD, FRCPC (CHA Bundang Medical Center, CHA University)	Dr. Lee has nothing to disclose.
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.
	No disclosure on file

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