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NCT07244549: COMMED

Chronic Outcome Monitoring for DBS in Dystonia

Recruiting now Last updated 24 November 2025
What this trial tests

trial in Dystonia in 25 participants. Currently enrolling.

Timeline
16 August 2024
Primary endpoint
30 March 2028
30 March 2028

Quick facts

Lead sponsorCharite University, Berlin, Germany
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment25
Start date16 August 2024
Primary completion30 March 2028
Estimated completion30 March 2028
Sites3 locations across Germany

Conditions studied

Sponsor

Charite University, Berlin, Germany

Who can join

Adults 5 to 80, any sex, with Dystonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Dystonia is a severe movement disorder involving increased muscular activity and can be very variable. To date, the treatment of dystonia is challenging. One effective therapy is deep brain stimulation (DBS), an invasive therapy, where stimulation electrodes are inserted in deep brain regions and a continuous electrical therapy is delivered via a pacemaker. However, the optimization of the therapy is a long process, up to months and there is no immediate adaptation to different disease states. This project aims to improve DBS therapy: The first aim is to learn more about electrical brain activity that could be the feedback signal for individualized therapy. Secondly, the investigators want to gather information about the long-term development of the signal and potential hints for optimal therapy locations that could be acutely used to accelerate therapy optimization. To date, recordings mainly in lab settings, have suggested low-frequency activity as a biomarker for dystonia. Biomarkers are signals that are changed with therapy and that reflect symptom severity. Further understanding of the low-frequency biomarker for dystonia and its applicability in everyday life is one of the objectives in this study. Therefore, using a pacemaker that can also record brain activity, biomarker activity will be recorded for 12 months. At the same time, development of clinical symptoms will be assessed using an application with weekly questionnaires on symptoms and a video diary. At monthly appointments for data saving, resting state as well as motor activity during a finger tapping task will be recorded to also assess the development of side-effects, such as stimulation-induced slowing, and their biomarkers.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Dystonia

Currently open trials in the same condition.

Other Charite University, Berlin, Germany trials

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