Real-world Outcomes Using DBS Systems with Directionality and Multiple Independent Current Control: USA Experience
Michael Okun1, Kelly Foote2, Theresa Zesiewicz3, Yarema Bezchlibnyk3, Alexander Papanastassiou4, Okeanis Vaou4, Jonathan Carlson5, Jason Aldred6, Vibhor Krishna7, Brian Dalm8, Corneliu Luca9, Jonathan Jagid9, Jennifer Durphy10, Julie Pilitsis11, Leonard Verhagen Metman12, Sepehr Sani13, Drew Kern14, Steven Ojemann15, Ritesh Ramdhani16, David Weintraub17, Bharathy Sundaram18, Abdolreza Siadati19, Derek Martinez20, Cong Zhi Zhao21, Mustafa Siddiqui22, Stephen Tatter23, Rajat Shivacharan24, Edward Goldberg24
1University of Florida, 2University of Florida - Normal Fixel Institute for Neurological Diseases, 3University of South Florida, 4UT Health San Antonio, 5Neurosurgery, Providence Inland Neurosurgery & Spine, 6Selkirk Neurology, 7University of North Carolina, Chapel Hill, 8The Ohio State University Wexner Medical Center, 9University of Miami School of Medicine, 10Albany Medical Center, 11University of Arizona Medical Center, 12Northwestern University, 13Rush University Medical Center, 14University of Colorado, 15University of Colorado Anschutz Medical Center, 16Northwell Health, 17Nassau University Medical Center, 18Texas Institute for Neurological DIsorders, 19Fort Worth Brain and Spine Institute, 20St. Luke's Regional Medical Center, 21St. Luke'S Neurology, 22Wake Forest University Medical Center, 23Wake Forest Univ School of Medicine, 24Boston Scientific Neuromodulation
Objective:
Here, we describe evaluation of real-world outcomes of Parkinson’s disease (PD) patients treated with directional Deep Brain Stimulation (DBS) systems using Multiple Independent Current Control (MICC ) at multiple U.S. centers.
Background:
DBS has been shown to reduce motor complications in PD with sustained benefits up to 10 years. Directional DBS systems with MICC may enhance programming flexibility and a wider therapeutic window, potentially improving efficacy while minimizing adverse effects. Real-world data from diverse clinical settings can provide valuable insights into the practical use and impact of these technologies.
Design/Methods:
This ongoing, prospective, multicenter registry study is designed to include up to 1,000 PD patients implanted at up to 50 U.S. sites using DBS systems (Vercise, Vercise PC, Gevia with Vercise/Cartesia Leads, Boston Scientific). Key assessments include PDQ-39, UPDRS/MDS-UPDRS, Clinical Global Impression of Change (CGI), Schwab and England Scale, and EQ-5D-5L. Safety data were collected through adverse event reporting.
Results:
To date, 196 subjects were enrolled, with 163 activating the DBS system. Patients had a mean age of 64.6 years, 70.3% male, and an average disease duration of 9.1-years. Motor function improved by 51% (25 points) at 6-months and was sustained at 1- and 2-years (21- and 22-points). Quality-of-life measures, assessed by the PDQ-39, demonstrated significant enhancements across multiple domains including mobility, activities of daily living, bodily discomfort, emotional well-being, and stigma. Over 90% of subjects and clinicians reported sustained benefits at 6-months and 2-years. No unanticipated adverse events occurred. The most common serious event was implant site infection (1.2%). Additional data collected will be analyzed and presented.
Conclusions:
Preliminary U.S. registry data demonstrate that directional DBS systems with MICC are associated with sustained improvements in motor function and quality of life in PD patients, aligning with previously published European outcomes. These findings support the clinical utility of advanced DBS technologies in real-world settings.
Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff.