Abstract Details

Title Real-World Clinical Outcomes Using a Novel Directional Lead from a DBS Registry for Parkinson's Disease

Topic Movement Disorders

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

Poster/Presentation
Number 3-004

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

Deep Brain Stimulation (DBS) systems have historically used ring-shaped electrodes that produce stimulation fields with limited control over field shape and volume of tissue activated. Directional current steering may permit a more personalized DBS approach with respect to individualized shape and pattern of electrical field and corresponding volume of tissue activated.

Design/Methods

The Vercise DBS Registry (ClinicalTrials.gov Identifier: NCT02071134) is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific. 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 included Unified Parkinson's disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson's disease Questionnaire (PDQ-39), Non-Motor Symptom Assessment Scale (NMSS) and Global Impression of Change.

Results

As of March 2019, 283 enrolled patients have been implanted with the directional lead. Change in PDQ-39 Summary Index demonstrated improvement in Quality of Life following DBS implant with the directional lead out to 6- (n=120) and 12-months (n=129) post-implant, respectively (p<0.001). Several sub-domains such as Activities of Daily Living, Bodily discomfort showed sustained improvement at 1-year post-implant (p<0.0001). Improvements in motor function (29 point improvement in MDS-UPDRS III scores-meds off condition) was observed at 12-months post-implant. Additional data is to be presented.

Conclusions

Enabling fractionalization of current using MICC can permit application of a well-defined, shaped, electrical field. This on-going registry represents the first comprehensive, large scale collection of real-world 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 .
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