Abstract Details

Title Clinical Efficacy of a Novel Deep Brain Stimulation System with 16-contact Directional Leads for the Treatment of Parkinson’s Disease

Topic Movement Disorders

Presentation(s) P1 - Poster Session 1 (8:00 AM-9:00 AM)

Poster/Presentation
Number 17-003

Objective Here, we describe the evaluation of the clinical efficacy and safety of a novel deep brain stimulation (DBS) system featuring 16-contact directional leads for the treatment of motor symptoms and quality of life in patients with Parkinson’s disease (PD).

Background Directional DBS leads can enhance therapeutic precision and reduce stimulation-induced side effects. A new directional DBS system introduces expanded 16-contact configurations (3-3-3-3-3-1 and 3-3-3-3-1-1-1-1) and multiple independent current control to tailor stimulation across multiple levels. This study investigates their impact on motor function, medication use, and quality of life in PD.

Design/Methods This prospective, multicenter, open-label trial (NCT#04577651) has so far enrolled 49 PD patients across 10 European centers. All subjects were implanted with the Vercise Genus DBS system (Boston Scientific) and activated postoperatively. The primary endpoint was change in MDS-UPDRS III (meds off) from baseline to 12 weeks post-activation. Secondary assessments included PDQ-39, LEDD, and adverse event monitoring. Follow-up visits occurred at 12 and 26 weeks, and annually through Year 2.

Results At 12 weeks, motor scores improved by 41% (mean reduction of 20 points), with sustained benefit at Year 1 (21-point) and Year 2 (22-point) follow-up (p<0.0001). Antiparkinsonian medication use decreased by 37% at 26 weeks and remained reduced through Year 2. PDQ-39 scores showed significant improvements in mobility, activities of daily living, bodily discomfort, and stigma domains. No unexpected adverse events were reported. Data collection is ongoing, and newly acquired results will be shared as they become available.

Conclusions The 16-contact directional DBS system demonstrated robust and sustained improvements in motor function, quality of life, and medication burden in PD patients. These findings support the safety and therapeutic value of multi-level directional stimulation and highlight its potential to optimize individualized neuromodulation strategies.

Authors/Disclosures
Rajat Shivacharan PRESENTER	Dr. Shivacharan has received personal compensation for serving as an employee of Boston Scientific.
Francesca Morgante, MD, PhD	Prof. Morgante has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Prof. Morgante has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic . Prof. Morgante has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific.
Cordula Matthies, MD, PhD	Prof. Matthies has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Prof. Matthies has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion/ Astra Zeneca. Prof. Matthies has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Boston Scientific. The institution of Prof. Matthies has received research support from German Research Council.
Saman Vinke, MD, PhD	The institution of Dr. Vinke has received research support from Boston Scientific.
Rick Schuurman, MD, PhD	Prof. Schuurman has nothing to disclose.
Veerle Visser-Vandewalle	Veerle Visser-Vandewalle has nothing to disclose.
Alireza Gharabaghi, MD	The institution of Prof. Gharabaghi has received research support from Boston Scientific. The institution of Prof. Gharabaghi has received research support from Medtronic. The institution of Prof. Gharabaghi has received research support from Abbott.
Volker Coenen	Volker Coenen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Ceregate. Volker Coenen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Inbrain. Volker Coenen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Cortec. Volker Coenen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for PRECISIS. Volker Coenen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Boston Scientific. Volker Coenen has stock in Ceregate. The institution of Volker Coenen has received research support from Boston Scientific.
James Fitzgerald (University of Oxford)	No disclosure on file
David Pedrosa (University Hospital Giessen and Marburg)	David Pedrosa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. David Pedrosa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bial. David Pedrosa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific Corp.. David Pedrosa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer. David Pedrosa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Desitin. David Pedrosa has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer. The institution of David Pedrosa has received research support from Boston Scientific Corp..
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.
Edward Goldberg, MD	Dr. Goldberg has received personal compensation for serving as an employee of Boston Scientific .

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