Chronic Outcome Monitoring for DBS in Dystonia

ConditionDystonia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-80
SponsorCharite University, Berlin, Germany

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

No trial groups listed

Sponsors and collaborators

Charite University, Berlin, Germany

Lead sponsor

Heinrich-Heine University, Duesseldorf

Collaborator

Hannover Medical School

Collaborator

Dystonia Medical Research Foundation

Collaborator