Objective: The objective of this study is to assess and report real-world outcomes of Dystonia patients implanted with Multiple Independent Current Control (MICC)-based directional Deep Brain Stimulation (DBS) systems.

Background: 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. DBS devices equipped with capabilities such as directionality and Multiple Independent Current Control (MICC) offer potential for improved neurostimulative precision. Here, we report a sub-analysis of patients with cervical dystonia only or dystonia with cervical involvement from an on-going, multicenter registry.

Method: This is a sub-analysis of patients with focal (cervical) dystonia only or cervical dystonia in the context of segmental or generalized dystonia assessed within a prospective, multicenter, international dystonia registry (NCT02686125). All patients receive an MICC-based, directional DBS system (Vercise, Boston Scientific). Patients are followed up to 3-years (post-implant). Several study assessments are being collected to evaluate their dystonia symptoms (e.g., TWSTRS), quality of life and overall satisfaction. Adverse Events are also collected.

Results: 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 cervical dystonia in context of segmental or generalized dystonia have been 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 cervical dystonia within frame of segmental or generalized dystonia, a 9.7-point and 7.3-point improvement in overall TWSTRS scores was noted at 6- (n=50) and 12-months (n=38), respectively.

Conclusion: 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 (alone or in context of segmental or generalized dystonia) following DBS.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/prospective-multicenter-international-registry-of-deep-brain-stimulation-for-dystonia-a-sub-analysis-of-cervical-dystonia-patients/