Clinical Efficacy of a Novel Deep Brain Stimulation System with 16-contact Directional Leads for the Treatment of Parkinson’s Disease
Francesca Morgante1, Cordula Matthies2, Saman Vinke3, Rick Schuurman4, Veerle Visser-Vandewalle5, Alireza Gharabaghi6, Volker Coenen7, James Fitzgerald8, David Pedrosa9, Andrea Kühn10, Rajat Shivacharan11, Edward Goldberg11
1St George's University of London, 2Julius-Maximilians-University Hospital Wuerzburg, 3Radboud University Medical Center, 4Academic Medical Centre (Amsterdam UMC), 5Uniklinik Köln, 6University Hospital Tübingen, 7University Medical Center Freiburg, 8University of Oxford, 9University Hospital Giessen and Marburg, 10Charité University Medicine, 11Boston Scientific Neuromodulation
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.
10.1212/WNL.0000000000213217
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