Real-World Outcomes Using a Novel Directional Lead From a Deep Brain Stimulation Registry for Parkinson's Disease

Abstract

Abstract INTRODUCTION 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. Here, we 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). METHODS The Vercise DBS Registry (ClinicalTrials.gov Identifier: NCT02071134) is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific Corporation. Subjects in this cohort 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 yr post-implantation where their overall improvement in quality of life and PD motor symptoms was evaluated. Clinical endpoints evaluated at baseline and during study follow included 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. RESULTS To date, a total of 232 subjects have been enrolled in this specific cohort. Improvement in motor function as assessed by UDPRSIII scores was sustained up to 1 yr post-implant representing a 34% reduction from baseline [n = 58, (P < .0001)]. Analysis of the PDQ-39 Summary Index demonstrated improvement in Quality of Life up to 1-yr post-implant (n = 106). Additional data, including full safety profile, will to be presented. CONCLUSION Enabling fractionalization of current using MICC can permit the application of a well-defined, shaped, electrical field. Use of a directional lead allows for the steering of current in horizontal directions by combining segmented leads and MICC. This DBS registry represents the first comprehensive, large scale collection of real-world outcomes and evaluation of safety and effectiveness of a multiple-source, constant-current directional DBS system.