Long-term brain-signal monitoring after GPi DBS for dystonia
Official title: Chronic Neurophyhsiological and Kinematic Biomarker Monitoring in Patients With Dystonia and Pallidal Deep Brain Stimulation
Run by Charite University, Berlin, Germany · NCT07244549 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 5 Years to 80 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 3 sites (Hanover, Lower Saxony and 2 other locations) |
| Status | Recruiting |
| Started | August 16, 2024 |
| Main results expected | March 30, 2028 |
| Study ends | March 30, 2028 |
| Registry record updated | November 24, 2025 |
| Trial ID | NCT07244549 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Investigating the relationship between genetic mutations and brain changes in dystonia
This study is trying to see how genetic changes linked to dystonia affect the brain in people with the condition compared to healthy individuals.
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Intraoperative Microelectrode Recordings with MAVEN vs Standard Equipment
This study tests whether MAVEN can match the recording data collected during DBS surgery for movement disorders using standard equipment.
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Low-intensity focused ultrasound for movement and seizure disorders
This trial will try low-intensity focused ultrasound (LIFUS) to see if it can safely change brain activity in people with movement disorders or epilepsy.
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Measuring brain network activity to predict and improve outcomes in children with dystonia
This project will test whether noninvasive brain and muscle recordings, and comparing DBS on versus off, can predict and help improve motor outcomes for children with dystonia.
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Wearable sensors to predict DBS results for people with dystonia
This study will test whether wearable sensors that record walking patterns before surgery can predict how well deep brain stimulation will work for people with dystonia.
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Using GPi brain signals to guide DBS programming for primary dystonia
This study will test whether recording local field potentials from the globus pallidus interna with the Medtronic Percept device can help guide DBS programming and improve symptoms in adults with primary dystonia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.