Actively Recruiting

Age: 5Years - 80Years
All Genders
NCT07244549

Chronic Outcome Monitoring for DBS in Dystonia

Led by Charite University, Berlin, Germany · Updated on 2025-11-24

25

Participants Needed

3

Research Sites

188 weeks

Total Duration

On this page

Sponsors

C

Charite University, Berlin, Germany

Lead Sponsor

H

Heinrich-Heine University, Duesseldorf

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Chronic Outcome Monitoring for DBS in Dystonia

Who Can Participate

Age: 5Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to give informed consent for the study, or in pediatric patients, legal guardian or parent willing to give informed consent
  • Diagnosis of dystonia, which may be isolated or generalized
  • Wish to receive surgical intervention with DBS to the internal pallidal globe (GPi)
  • Decision to receive the sensing-enabled neurostimulator (Percept neurostimulator) PC/RC
  • Age 5-80 years
Not Eligible

You will not qualify if you...

  • Severe psychiatric disorders (BDI > 20)
  • Other severe medical conditions that may interfere with successful participation in the study protocol
  • No consent given

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany, 30625

Actively Recruiting

2

Heinrich Heine University

Düsseldorf, Nordrhein-Westfahlen, Germany, 40225

Actively Recruiting

3

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, Germany, 10117

Actively Recruiting

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Research Team

A

Andrea A Kuehn, MD

CONTACT

L

Lucia K Feldmann, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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