Chronic Neurophyhsiological and Kinematic Biomarker Monitoring in Patients With Dystonia and Pallidal Deep Brain Stimulation

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Charité Universitätsmedizin Berlin
RECRUITING
Berlin
Heinrich Heine University
RECRUITING
Düsseldorf
Medizinische Hochschule Hannover
RECRUITING
Hanover
Contact Information
Primary
Andrea A Kuehn, MD
andrea.kuehn@charite.de
0049 30 450 660 203
Backup
Lucia K Feldmann, MD
lucia.feldmann@charite.de
0049 30 450 660 296
Time Frame
Start Date: 2024-08-16
Estimated Completion Date: 2028-03-30
Participants
Target number of participants: 25
Sponsors
Collaborators: Dystonia Medical Research Foundation, Heinrich-Heine University, Duesseldorf, Hannover Medical School
Leads: Charite University, Berlin, Germany

This content was sourced from clinicaltrials.gov

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