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Abstract Details

Real-World Outcomes in USA using DBS Systems with Directionality and Multiple Independent Current Control
Movement Disorders
P5 - Poster Session 5 (11:45 AM-12:45 PM)
5-017

Randomized controlled trials have demonstrated that DBS can be an effective strategy for reducing the motor complications in PD (Okun 2012, Schuepbach, 2013, Vitek 2020) with potential for sustained improvement greater than 10-years (Deuschl 2013). However, large, multi-center, real-world data can reveal insights in the care of PD patients when DBS is used per standard-of-care.

To characterize real-world data (USA experience) with the use of directional Deep Brain Stimulation (DBS) systems with multiple-independent current control (MICC) in the treatment of Parkinson’s Disease (PD).

Prospectively enrolled participants are implanted with Vercise DBS systems (Boston Scientific), a multiple-source, constant-current system, and are assessed up to 3-years post-implantation. Clinical measures recorded at baseline and during study follow-up include MDS-Unified Parkinson's disease Rating Scale (MDS-UPDRS), Parkinson's Disease Questionnaire (PDQ-39), Global Impression of Change (GIC) , and Non-Motor Symptom Assessment Scale (NMSS). Adverse events and device-related complications are also collected.

A total of 106-patients (mean age: 63.8 ± 8.7 years, 73% male, disease duration 9.9-years) have been enrolled, and 82 have had their device activated. At 6-months (n = 56), an 8.3-point improvement in PDQ-39 Summary Index (27.1 à 18.8, p<0.0001) was noted, thereby representing a clinically significant improvement in quality of life (MCID >4.7-points) (Horvath 2017). According to GIC, all patients (100%) and 95% of clinicians reported improvement at 6-months. No lead breakage or unanticipated adverse events reported.

Real-world outcomes from this large, prospective, multi-center outcomes study demonstrate improvement in quality of life following DBS, and a high global impression of improvement among patients and clinicians. Data from this study will continue to provide insight regarding the application of the MICC-based directional DBS Systems for PD in clinical practice.

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.
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 intellectual property interests from a discovery or technology relating to health care.
Yarema B Bezchlibnyk Yarema B Bezchlibnyk has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for PMT Corporation. Yarema B Bezchlibnyk has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Yarema B Bezchlibnyk has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. Yarema B Bezchlibnyk has received personal compensation in the range of $0-$499 for serving as a Consultant for Medtronic.
Alexander M. Papanastassiou Alexander M. Papanastassiou has received intellectual property interests from a discovery or technology relating to health care.
Jonathan Carlson Jonathan Carlson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for medtronic.
Jason Lamar Aldred, MD, FAAN (Selkirk Neurology) Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Boston Scientific. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Abbvie. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan . Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Quadralynx. Dr. Aldred 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. 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 Boston Scientific. 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 Medtronic. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie. Dr. Aldred has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Aldred has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Adamas. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Allergan. Dr. Aldred has received personal compensation in the range of $50,000-$99,999 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 $10,000-$49,999 for serving on a Speakers Bureau for Medtronic. Dr. Aldred has received personal compensation in the range of $5,000-$9,999 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 $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Aldred has received personal compensation in the range of $100,000-$499,999 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 Atara. The institution of Dr. Aldred has received research support from Takeda. 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 Theravance. The institution of Dr. Aldred has received research support from Triplet Therapeutics. The institution of Dr. Aldred has received research support from UCB. The institution of Dr. Aldred has received research support from Cerevel . 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 Athira. The institution of Dr. Aldred has received research support from IRL. The institution of Dr. Aldred has received research support from NeuroDerm.
Vibhor Krishna Vibhor Krishna has nothing to disclose.
Aristide Merola, MD, PhD (The Ohio State University) Dr. Merola has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Merola has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbott. Dr. Merola 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 in Neurology.
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.
Jonathan Jagid Jonathan Jagid has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic Inc. The institution of Jonathan Jagid has received research support from Boston Scientific. The institution of Jonathan Jagid has received research support from Medtronic Inc.
Jennifer Lyn 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.
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.
Sepehr Sani Sepehr Sani has nothing to disclose.
Steven Ojemann Steven Ojemann has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Steven Ojemann has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Voyager Therapeutics. The institution of Steven Ojemann has received research support from Voyager Therapeutics.
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.
David Weintraub, MD (Northwell Health) Dr. Weintraub has nothing to disclose.
Ritesh Ramdhani, MD (Northwell Health) Dr. Ramdhani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Accorda. Dr. Ramdhani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amneal. The institution of Dr. Ramdhani has received research support from NIH. Dr. Ramdhani has received research support from Parkinson Alliance.
Abdolreza Siadati, MD Dr. Siadati has nothing to disclose.
Bharathy E. Sundaram, MD (Texas Institute for Neurological DIsorders) Dr. Sundaram 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.
Derek Martinez, MD Dr. Martinez has nothing to disclose.
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 Abbvie. Dr. Siddiqui has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for United States Department of Justice. The institution of Dr. Siddiqui has received research support from Boston Scientific Neuromodulation. The institution of Dr. Siddiqui has received research support from Abbvie. Dr. Siddiqui has received research support from Michael J. Fox Foundation. 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 .
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.