Real-World Clinical Outcomes Using a Novel Directional Lead from a DBS Registry for Parkinson’s Disease (1385)

Objective: In this report, initial real-world outcomes using a directional lead with a Deep Brain Stimulation (DBS) system capable of multiple independent current source control (MICC) for use in managing symptoms of levodopa-responsive Parkinson’s disease (PD) are reported. Background: Deep Brain Stimulation (DBS) systems have historically 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 individualized shape and pattern of electrical field and corresponding volume of tissue activated. Design/Methods: The Vercise DBS Registry (ClinicalTrials.gov Identifier: NCT02071134) is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific. Subjects were implanted with a directional lead included as part of a multiple-source, constant-current directional DBS system (Vercise Cartesia, Boston Scientific). Subjects were followed up to 3-years post-implantation where their overall improvement in quality of life and PD motor symptoms was evaluated. Clinical endpoints included Unified Parkinson’s disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson’s disease Questionnaire (PDQ-39), Non-Motor Symptom Assessment Scale (NMSS) and Global Impression of Change. Results: As of March 2019, 283 enrolled patients have been implanted with the directional lead. Change in PDQ-39 Summary Index demonstrated improvement in Quality of Life following DBS implant with the directional lead out to 6- (n=120) and 12-months (n=129) post-implant, respectively (p Conclusions: Enabling fractionalization of current using MICC can permit application of a well-defined, shaped, electrical field. This on-going registry represents the first comprehensive, large scale collection of real-world outcomes using a directional lead and an MICC-based DBS system. 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. 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 received research support from Boston Scientific. Dr. Paschen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Medtronic, Desitin, AbbVie and Boston Scientific. Dr. Kuehn has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific, Medtronic, and Abbott. Dr. Volkmann has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with grants and personal fees from Boston Scientific and Medtronic as well as personal fees from Allergan, Merz, UCB, AbbVie, TEVA, Zambon, and Bial. 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. Vesper has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Abbott, Boston Scientific, and ATI. Dr. Vesper has received research support from Abbott and MDT.