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Abstract Details

Real-world Outcomes Using DBS Systems with Directionality and Multiple Independent Current Control: USA Experience
Movement Disorders
P1 - Poster Session 1 (8:00 AM-9:00 AM)
3-007
Here, we present preliminary outcomes from an ongoing prospective, multicenter outcomes registry conducted at centers in the United States consisting of patients implanted with directional Deep Brain Stimulation (DBS) Systems capable of multiple independent current control (MICC) for use in management of the motor signs and symptoms in Ievodopa-responsive Parkinson's disease (PD).  
DBS is an effective strategy for reducing PD motor complications.  Clinical data collected from a wide variety of implanting centers (based on standard of care) treating PD patients may help provide addtional insights regarding real-world, clinical use and outcomes of DBS.
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 MDS-Unified Parkinson's disease Rating Scale (MDS-UPDRS), Parkinson's Disease Questionnaire (PDQ-39), Global Impression of Change (GIC), and the Non-Motor Symptom Assessment Scale (NMSS). Adverse events and device-related complications were also collected. 
To date, a total of 141-subjects (mean age: 64.0 ± 9.0 years, 71.5% male, disease duration 9.4 ± 5.1 years, n=137) have been enrolled to date, and 116 of these have undergone device activation. A 53.4% improvement (27-points, p<0.0001) in motor function was noted at 6-months as assessed by the MDS-UPDRS III in the "off'' medication condition.  At 6-months follow-up, over 95% of subjects and over 90% of clinicians noted improvement as compared with Baseline. To date, no lead fractures or unanticipated adverse events were reported. Additional and updated data will be presented. 
Real-world outcomes from this large, prospective, multicenter outcomes registry demonstrated improvement in motor function, quality-of-life, and satisfaction following DBS. 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.
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.
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.
Alexander M. Papanastassiou Alexander M. Papanastassiou has received intellectual property interests from a discovery or technology relating to health care.
Juan L. Ramirez Castaneda, MD (Methodist Physicians. Neurosurgery and Neurology Specialists) Dr. Ramirez Castaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. Dr. Ramirez Castaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie . Dr. Ramirez Castaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Ramirez Castaneda has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus. Dr. Ramirez Castaneda has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie .
Jonathan Carlson No disclosure on file
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.
Vibhor Krishna No disclosure on file
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.
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.
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.
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 The institution of Sepehr Sani has received research support from NIH. Sepehr Sani has received intellectual property interests from a discovery or technology relating to health care. Sepehr Sani has received publishing royalties from a publication relating to health care.
Steven Ojemann The institution of Steven Ojemann has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alpha omega engineering. The institution of 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 Kenai Therapeutics. Steven Ojemann has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Insightec. Steven Ojemann has stock in Phasor inc.
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.
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.
David Weintraub (Nassau University Medical Center) No disclosure on file
Abdolreza Siadati Abdolreza 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 Derek 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 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 .
Edward Goldberg (Boston Scientific) No disclosure on file