Improvement in Cervical Dystonia – Outcomes of a Prospective, Multicenter, International Registry of Deep Brain Stimulation (DBS) (P11-11.002)

Abstract

<h3>Objective:</h3> To report real-world outcomes of Dystonia patients implanted with a Multiple Independent Current Control (MICC)-based Directional DBS system. <h3>Background:</h3> Management of dystonia using Deep Brain Stimulation (DBS) is a well-established therapeutic approach. However, optimal DBS target sites in patients with cervical (focal) versus generalized dystonia are thought to diverge and be specific for particular connections (Horn 2022). DBS devices equipped with capabilities such as directionality and Multiple Independent Current Control (MICC) may offer potential for improved clinical outcomes. Here, we report a sub-analysis of patients with cervical dystonia only or dystonia with cervical involvement from an on-going, multicenter registry. <h3>Design/Methods:</h3> In this prospective, on-label, multi-center, international registry (ClinicalTrials.gov Identifier: NCT02686125) of dystonia, enrolled subjects received MICC-based directional DBS systems (Vercise, Boston Scientific). Subjects were followed up to 3 years (post-implant). Several study assessments evaluating their dystonia symptoms (e.g., TWSTRS), quality of life (GIC) and overall satisfaction were administered. Adverse Events were also collected. <h3>Results:</h3> A total of 43-patients (mean age 56.9-years, 58% females) with focal (cervical) dystonia only and 83-patients (mean 41.95-years, 61% females) with generalized or segmental dystonia with cervical involvement who underwent pallidal DBS were prospectively evaluated. Both groups reported significant improvement in overall TWSTRS scores – however the extent varied. In the cervical only cohort, a 19.9-point improvement was noted at 6-months (n=25) and sustained up to 1-year (23.2-point improvement, n=20). In those with generalized or segmental dystonia (with cervical involvement), a 9.7-point. and 7.3-improvement in overall TWSTRS scores was noted at 6- (n = 50) and 12-months (n = 38), respectively. <h3>Conclusions:</h3> This registry represents the first comprehensive, large-scale collection of real-world outcomes associated with dystonia patients implanted with a directional DBS system capable of MICC. Preliminary results demonstrate significant improvement in patients with cervical dystonia (either alone or with other regions involved) following DBS. <b>Disclosure:</b> Dr. Albanese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Albanese has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers Publishing Group. Dr. Albanese has a non-compensated relationship as a President-Elect with International Association on Parkinsonism and Related Disorders that is relevant to AAN interests or activities. Roshini Jain has received personal compensation for serving as an employee of Boston Scientific. Roshini Jain has received stock or an ownership interest from Boston Scientific. Lilly Chen has received personal compensation for serving as an employee of Boston Scientific . Joachim Krauss has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inomed. Joachim Krauss has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for aleva. Joachim Krauss has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston.