Journal Article

DZNE-2026-00741

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png The chronical outcome monitoring in dystonia with deep brain stimulation (COMEDD) study protocol: a longitudinal evaluation of chronic electrophysiological biomarkers in patients with dystonia and deep brain stimulation therapy

Feldmann, L. K. ; Kaplan, J. ; de Almeida Marcelino, A. L. ; Schulze, D. ; Kühn, A. A. (Last author)DZNE*

2026
Frontiers Media SA Lausanne

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Please use a persistent id in citations: doi:10.3389/dyst.2026.16304

Abstract: Introduction: Deep brain stimulation is an effective therapy for patients with isolated dystonia. In pallidal local field potential recordings, theta was identified as a biomarker for symptom severity, and beta as a transdiagnostic biomarker for bradykinesia. However, challenges remain: 1) programming can be a lengthy process, and to date there is no guidance by electrophysiological biomarkers; 2) temporal dynamics of stimulation effects, but also of stimulation-induced side-effects are not understood; 3) electrophysiological characteristics for dystonia subtypes or non-responders are unknown.Materials and protocol outline: This is the protocol for an observational, prospective, long-term study for the systematic identification of electrophysiological pallidal biomarkers in patients with dystonia and a newly implanted sensing-enabled deep brain stimulation system. We expect a recruitment of 25–30 patients to be sufficient to track changes in chronic biomarkers and symptom severity. The protocol consists of two strategies for data collection in the same patient cohort over 12 months after deep brain stimulation surgery: 1) continuously recorded chronic peak biomarker activity with weekly home monitoring; 2) monthly in-hospital recordings of local field potential data at 250 Hz sampling rate during rest and motor activity and during stimulation ON/OFF. Two patients have completed the study protocol with an appointment adherence of 92%, underlining the feasibility of the study protocol.Discussion: We here present a feasible, systematic protocol for identification of electrophysiological biomarkers in dystonia to establish electrophysiology-based guidance of therapy optimization in dystonia. Progress of the study can be followed in the study registration log: NCT07244549.

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Contributing Institute(s):

1. Movement Disorders (Parkinson's disease, Dystonia) (AG Kühn)

Research Program(s):

1. 353 - Clinical and Health Care Research (POF4-353) (POF4-353)

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