About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Severe psychiatric disorders (BDI>20)
Other severe medical conditions, that may interfere with the successful paritcipation in the study protocol
No consent given
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Charite University, Berlin, Germany
Lead sponsor
Heinrich-Heine University, Duesseldorf
Collaborator
Hannover Medical School
Collaborator
Dystonia Medical Research Foundation
Collaborator