NCT07244549 Chronic Outcome Monitoring for DBS in Dystonia
| NCT ID | NCT07244549 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Dystonia |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-08-16 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2024-08-16 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Severe psychiatric disorders (BDI\>20) * Other severe medical conditions, that may interfere with the successful paritcipation in the study protocol * No consent given
Contact & Investigator
Andrea A Kuehn, MD
STUDY DIRECTOR
Charite University, Berlin, Germany
Frequently Asked Questions
Who can join the NCT07244549 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 80 Years, studying Dystonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07244549 currently recruiting?
Yes, NCT07244549 is actively recruiting participants. Contact the research team at andrea.kuehn@charite.de for enrollment information.
Where is the NCT07244549 trial being conducted?
This trial is being conducted at Hanover, Germany, Düsseldorf, Germany, Berlin, Germany.
Who is sponsoring the NCT07244549 clinical trial?
NCT07244549 is sponsored by Charite University, Berlin, Germany. The principal investigator is Andrea A Kuehn, MD at Charite University, Berlin, Germany. The trial plans to enroll 25 participants.