Abstract Details

Title Long-term Outcomes in Patients Implanted with DBS Systems Capable of Directionality and Multiple Independent Current Control

Topic Movement Disorders

Presentation(s) P2 - Poster Session 2 (8:00 AM-9:00 AM)

Poster/Presentation
Number 5-024

Objective This on-going registry seeks to collect/analyze real-world clinical outcomes out to 2-years follow-up in levodopa-responsive Parkinson's disease (PD) patients implanted with DBS systems equipped with Multiple Independent Current Control (MICC) and Directionality.

Background Tracking those being treated for PD motor symptoms offers insight regarding the outcomes associated with the implanted DBS systems that are utilized by patients in the real-world clinical setting.

Design/Methods Prospectively-enrolled participants were implanted with Vercise DBS systems (Boston Scientific), a multiple-source, constant-current system, and assessed up to 3-years post-implantation as part of an on-going DBS patient outcomes registry (clinicaltrials.gov identifier: NCT02071134). Clinical measures recorded at baseline and during follow-up included MOS-Unified Parkinson's disease Rating Scale (MDS-UPDRS), Parkinson's Disease Questionnaire (PDQ-39), Global Impression of Change (GI(), and the Non-Motor Symptom Assessment Scale (NMSS). Adverse events and device-related complications are also collected.

Results

Enrollment and device activation consists of 174-subjects (mean age: 64.2 ± 8.7 years, 68.5% male, disease duration 9.3 ± 5.1 years, n = 168) and 142-subjects, respectively. Assessment of MDS-UPDRS Ill in "off" medication condition demonstrated a 51% improvement (25-points, p<0.0001) in motor function at 6-months. This level of motor function improvement was maintained out to 1-year (22-point improvement) and to 2-years (24-point improvement) follow-up. As compared with baseline, over 93% of patients and over 89% of clinicians noted improvement (GIC) at 6-, 12-, and 24-months follow-up. Outcomes were improved in various quality life measures (PDQ-39): mobility, activities of daily living, bodily discomfort, emotional well-being, and stigma. To date, no lead fractures or unanticipated adverse events were reported. Additional results derived from on-going data collection will be presented.

Conclusions Following DBS, outcomes derived from this on-going multicenter, prospective registry demonstrated improved motor function, quality-of-life, and satisfaction. This on-going registry will continue to provide insight regarding application of MICC-based directional DBS systems for PD as applied in real-world settings.

Authors/Disclosures
Michael S. Okun, MD, FAAN (University of Florida) PRESENTER	Dr. Okun has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for NIH. Dr. Okun has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Parkinson's Foundation. Dr. Okun has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JAMA Neurology. Dr. Okun has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for NEJM Journal Watch. The institution of Dr. Okun has received research support from NIH. The institution of Dr. Okun has received research support from Parkinson's Foundation. The institution of Dr. Okun has received research support from Tourette Association of America. The institution of Dr. Okun has received research support from Michael J Fox. Dr. Okun has received publishing royalties from a publication relating to health care.
Yarema Bezchlibnyk	Yarema Bezchlibnyk has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. Yarema Bezchlibnyk has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for PMT Inc. Yarema Bezchlibnyk has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbott. Yarema Bezchlibnyk has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Boston Scientific. Yarema Bezchlibnyk has received research support from Medtronic.
Kelly D. Foote, MD	Kelly D. Foote, MD has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axio/Neurocrine Biosciences.
Theresa A. Zesiewicz, MD (University of South Florida)	Dr. Zesiewicz has received personal compensation for serving as an employee of Medscape. Dr. Zesiewicz has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lexeo. Dr. Zesiewicz has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Steminent. Dr. Zesiewicz has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Larimar. Dr. Zesiewicz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Zesiewicz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Zesiewicz has received intellectual property interests from a discovery or technology relating to health care. Dr. Zesiewicz has received intellectual property interests from a discovery or technology relating to health care. Dr. Zesiewicz has received intellectual property interests from a discovery or technology relating to health care.
Alexander M. Papanastassiou	Alexander M. Papanastassiou has received intellectual property interests from a discovery or technology relating to health care.
Okeanis Vaou, MD, FAAN (UT San Antonio)	Dr. Vaou has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ABBVIE. Dr. Vaou has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Vaou has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic . Dr. Vaou has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for medtronic. An immediate family member of Dr. Vaou has stock in SAGE. The institution of Dr. Vaou has received research support from Medtronic.
Jason L. Aldred, MD, FAAN (Selkirk Neurology)	Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan . Dr. Aldred has received personal compensation in the range of $0-$499 for serving as a Consultant for Quadralynx. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Boston Scientific. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for TEVA. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for US World Meds. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Arete Neuroscience, PLLC. The institution of Dr. Aldred has received research support from Biogen . The institution of Dr. Aldred has received research support from Abbvie. The institution of Dr. Aldred has received research support from Merz. The institution of Dr. Aldred has received research support from AstraZeneca. The institution of Dr. Aldred has received research support from Neurocrine. The institution of Dr. Aldred has received research support from Aptinyx. The institution of Dr. Aldred has received research support from Cerevance. The institution of Dr. Aldred has received research support from Boston Scientific . The institution of Dr. Aldred has received research support from Parkinson Foundation . The institution of Dr. Aldred has received research support from Roche. The institution of Dr. Aldred has received research support from Sage Therapeutics. The institution of Dr. Aldred has received research support from Annovis. The institution of Dr. Aldred has received research support from Biovie. The institution of Dr. Aldred has received research support from NeuroDerm. The institution of Dr. Aldred has received research support from PhotoPharma. The institution of Dr. Aldred has received research support from Lilly.
Jonathan Jagid	Jonathan Jagid has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Miami Dade County State Attorneys office. The institution of Jonathan Jagid has received research support from Boston Scientific.
Corneliu C. Luca, MD (University of Miami)	Dr. Luca has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Boston Scientific. Dr. Luca has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Signant Health. Dr. Luca has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott.
Vibhor Krishna	No disclosure on file
Brian Dalm, MD	Dr. Dalm has nothing to disclose.
Jennifer L. Durphy, MD (Albany Medical Center)	Dr. Durphy has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Acorda.
Julie Pilitsis	Julie Pilitsis has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbott. Julie Pilitsis has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Aim Medical Robotics . Julie Pilitsis has stock in Aim Medical Robotics . The institution of Julie Pilitsis has received research support from Medtronic. The institution of Julie Pilitsis has received research support from Boston Scientific. The institution of Julie Pilitsis has received research support from Abbott. The institution of Julie Pilitsis has received research support from Focused Ultrasound Foundation. The institution of Julie Pilitsis has received research support from NIH 2R01CA166379. The institution of Julie Pilitsis has received research support from NIH R01EB030324. The institution of Julie Pilitsis has received research support from NIH-NeuroBlueprint MedTech 5U54EB033650.
Leonard Verhagen Metman, MD, PhD (Northwestern University)	Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Verhagen Metman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mitsubishi Tanabe. Dr. Verhagen Metman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Supernus. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cerevel. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers.
Drew S. Kern, MD, FAAN (University of Colorado)	Dr. Kern has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. The institution of Dr. Kern has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. The institution of Dr. Kern has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Kern has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. The institution of Dr. Kern has received research support from Boston Scientific. The institution of Dr. Kern has received research support from AbbVie Pharmaceticals. Dr. Kern has received research support from Medtronic.
Yarema Bezchlibnyk	Yarema Bezchlibnyk has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. Yarema Bezchlibnyk has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for PMT Inc. Yarema Bezchlibnyk has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbott. Yarema Bezchlibnyk has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Boston Scientific. Yarema Bezchlibnyk has received research support from Medtronic.
Ritesh Ramdhani, MD (Northwell Health)	Dr. Ramdhani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Encora Therapeutics. Dr. Ramdhani has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Encora Therapeutics. The institution of Dr. Ramdhani has received research support from NIH. Dr. Ramdhani has received research support from Parkinson Alliance. Dr. Ramdhani has received intellectual property interests from a discovery or technology relating to health care.
Bharathy E. Sundaram, MD (Texas Institute for Neurological DIsorders)	Dr. Sundaram has nothing to disclose.
Derek Martinez	Derek Martinez has nothing to disclose.
Cong Zhi Zhao, MD (St. Luke'S Neurology)	Dr. Zhao has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Efficient CME. Dr. Zhao has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva.
Mustafa S. Siddiqui, MD, FAAN	Dr. Siddiqui has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Boston Scientific Neuromodulation. Dr. Siddiqui has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic. The institution of Dr. Siddiqui has received research support from Boston Scientific Neuromodulation. The institution of Dr. Siddiqui has received research support from Abbvie. The institution of Dr. Siddiqui has received research support from National Institute of Health .
Stephen B. Tatter, MD (Wake Forest Univ School of Medicine)	The institution of Dr. Tatter has received research support from Monteris Medical, Inc. The institution of Dr. Tatter has received research support from Arbor Pharmaceuticals. Dr. Tatter has received intellectual property interests from a discovery or technology relating to health care.
Lilly Chen (Boston Scientific)	Lilly Chen has received personal compensation for serving as an employee of Boston Scientific .
Rajat Shivacharan	Dr. Shivacharan has received personal compensation for serving as an employee of Boston Scientific.
Jonathan Jagid	Jonathan Jagid has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Miami Dade County State Attorneys office. The institution of Jonathan Jagid has received research support from Boston Scientific.
Edward Goldberg, MD	Dr. Goldberg has received personal compensation for serving as an employee of Boston Scientific .

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