Chronic Outcome Monitoring for DBS in Dystonia
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- 5 és 80 év között vagy?
Forrás: NCT07244549: ki vehet részt
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Charite University, Berlin, Germany
- Azonosító
- NCT07244549
- A regiszteradat frissítve
- 2025. november 24.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Chronic Neurophyhsiological and Kinematic Biomarker Monitoring in Patients With Dystonia and Pallidal Deep Brain Stimulation
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.
Bevonási feltételek: 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.
Kizáró feltételek: Severe psychiatric disorders (BDI>20); Other severe medical conditions, that may interfere with the successful paritcipation in the study protocol; No consent given.