Real-World Outcomes Using a Novel Directional Lead from a Registry of DBS for Parkinson’s Disease (P4.056)

Objective: To report initial real-world outcomes using a directional lead with a DBS System capable of multiple independent current source control (MICC) for use in managing symptoms of levodopa-responsive Parkinson’s disease (PD). Background: Deep Brain Stimulation (DBS) systems historically have used ring-shaped electrodes that produce stimulation fields with limited control over field shape and volume of tissue activated. Directional current steering may permit a more personalized DBS approach with respect to the individualized shape and pattern of the electrical field and corresponding volume of tissue activated. Design/Methods: The Vercise DBS Registry is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific. The Vercise PC system (Boston Scientific) is a CE-marked, multiple-source constant current system with a non-rechargeable battery. Subjects will be followed up out to 3 years post-implantation. Clinical endpoints will be evaluated at baseline and during study follow up that include Unified Parkinson’s disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson’s disease Questionnaire (PDQ-39), and Global Impression of Change. Adverse events are also collected. Subjects in this specific cohort were implanted with a directional lead (Vercise Cartesia, Boston Scientific) included as part of a directional DBS system for bilateral STN-DBS. Results: Over 100 subjects have been enrolled in this specific cohort. A 6.1 ± 12.11 (n = 73) point improvement was noted in the PDQ-39 Summary Index at the 6-month interval compared with Baseline and this improvement continued up to 1 year post-implant. Subjects, clinicians, and caregivers reported over 90% improvement in the symptoms at 6 months post-lead implant as compared with Baseline and was maintained up to the 12-month interval. Additional data is to be presented. Conclusions: Enabling fractionalization of current using MICC can permit the application of a well-defined, shaped electrical field. Use of a directional lead allows for steering of current in horizontal directions by combining segmented leads and MICC. Study Supported by: Boston Scientific Disclosure: Dr. Deuschl has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Deuschl has received personal compensation in an editorial capacity for European Academy of Neurology President. Dr. Deuschl has received royalty, license fees, or contractual rights payments from Thieme publishers. Dr. Deuschl has received research support from Medtronic: Earlystim study, Boston scientific: Vercise study (through institution). Dr. Jain has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Jain has received research support from Boston Scientific. Dr. Scholtes has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Wang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Barbe has nothing to disclose. Dr. Potter-Nerger has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with received lecture fees from St. Jude, grants from Medtronic, study fees from Boston Scientific, and has been serving as consultant for Abbvie and Licher. Dr. Potter-Nerger has received research support from Boston Scientific. Dr. Kuehn has nothing to disclose. Dr. Volkmann has nothing to disclose. Dr. Paschen has nothing to disclose. Dr. Vesper has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientiifc, Abbott. Dr. Vesper has received research support from Boston Scientific, Abbott.