Long-term brain-signal monitoring after GPi DBS for dystonia
Chronic Neurophyhsiological and Kinematic Biomarker Monitoring in Patients With Dystonia and Pallidal Deep Brain Stimulation
This project will try to find brain-signal patterns recorded from a sensing-enabled DBS device in people with dystonia to help personalize and speed up stimulation care over the first postoperative year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 5 Years to 80 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 3 sites (Hanover, Lower Saxony and 2 other locations) |
| Trial ID | NCT07244549 on ClinicalTrials.gov |
What this trial studies
This is an observational, multicenter project enrolling people with dystonia who are receiving GPi deep brain stimulation with the Percept sensing-enabled neurostimulator. The device will record intracranial local field potentials, including during active stimulation, and researchers will track these signals repeatedly over the first year after surgery. The team will examine low-frequency (theta/alpha) and beta-band activity, day/night (circadian) changes, and how signal patterns relate to symptom changes and stimulation settings. The goal is to identify chronic electrophysiological biomarkers that could guide faster and more individualized DBS programming or future closed-loop approaches.
Who should consider this trial
Good fit: Ideal candidates are people aged 5–80 with a clinical diagnosis of dystonia who plan to receive GPi DBS and agree to have the sensing-enabled Percept neurostimulator implanted and to attend follow-up visits.
Not a fit: Patients who will not receive a sensing-enabled device, are not undergoing GPi DBS, or have severe psychiatric or medical comorbidities that preclude participation are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the findings could shorten the time needed to find effective DBS settings and enable more personalized or automatic stimulation adjustments to improve symptoms.
How similar studies have performed: Prior laboratory recordings and a small number of case reports have suggested low-frequency activity as a dystonia biomarker, but systematic long-term data with the Percept device in dystonia are currently limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hanover, Lower Saxony and 2 other locations
- Medizinische Hochschule Hannover — Hanover, Lower Saxony, Germany (Recruiting)
- Heinrich Heine University — Düsseldorf, Nordrhein-Westfahlen, Germany (Recruiting)
- Charité Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Andrea A Kuehn, MD
- Email: andrea.kuehn@charite.de
- Phone: 0049 30 450 660 203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.