Objective: The objective of this device registry entails collecting clinical outcomes, economic value and technical performance of a Deep Brain Stimulation (DBS) system capable of multiple independent current control (MICC) for use in the treatment of dystonia.

Background: Several studies have now published clinical outcomes using DBS for the treatment of dystonia encompassing a range of dystonic conditions including primary generalized, cervical dystonia, tardive dystonia, and other types of secondary dystonia, and all have reported effective results with use of DBS for the treatment of dystonia. Here we report the initial outcomes from a multi-center registry of dystonia patients implanted with an MICC-based DBS system.

Methods: This is a prospective, on-label, multi-center, international registry study consisting of up to 200 patients implanted with a DBS system (Vercise, Boston Scientific) for use in the treatment of dystonia followed out to 3 years (post-implant) at up to 40 sites in Europe. Study assessments conducted will be based on dystonia sub-group, classification, and age and include (but not limited) to the following: Burke-Fahn-Marsden Dystonia Rating Scale, Clinical Global Impression of Change, Global Dystonia Scale, SF-36v2 or SF-10v2 Health Survey, and Toronto Western Spasmodic Torticollis Rating Scale.

Results: Initial results of this on-going registry of DBS outcomes in dystonia patients will be reported.

Conclusions: Large patient data registries may facilitate insights regarding real-world, clinical use of DBS. This registry represents the first comprehensive, large scale collection of outcomes associated with dystonia patients implanted with a DBS system capable of multiple independent current control (MICC) and will include assessment of economic value and device technical performance.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-registry-of-real-world-outcomes-using-deep-brain-stimulation-for-the-treatment-of-dystonia/