Deep cerebellar (dentate nucleus) stimulation for post-stroke spasticity and movement problems
Official title: Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.
Run by Jan Biziel University Hospital No 2 in Bydgoszcz · NCT07190092 · Data updated 2026-11-12
This trial will try deep brain stimulation near the dentate nucleus to reduce limb spasticity and improve movement in people 9–36 months after a single stroke.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Jan Biziel University Hospital No 2 in Bydgoszcz Academic / other |
| Locations | 1 site (Bydgoszcz) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | December 30, 2027 |
| Study ends | December 30, 2028 |
| Registry record updated | September 24, 2025 |
| Trial ID | NCT07190092 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 9–36 months after a single ischemic or hemorrhagic stroke with persistent spastic paresis of at least one limb who completed prior rehabilitation, had no recent improvement, and have no contraindications to DBS or MRI.
✕Probably not a fit
Patients with post-stroke seizures, severe sensory deficits, anosognosia, moderate to severe hemispatial neglect, active depression, or other contraindications to surgery or MRI are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study implants a deep brain stimulation electrode targeting the dentate-rubro-thalamic tract (DRTt) near the dentate nucleus on the side of the body affected by spasticity. Each participant receives initial stimulation at 130 Hz combined with a 4–6 week rehabilitation program, followed by a switch to 70 Hz with repeat clinical evaluations to compare effects. Eligible adults have a single ischemic or hemorrhagic stroke 9–36 months earlier with persistent spastic paresis and prior rehabilitation but no recent improvement. Primary outcomes focus on changes in spasticity and motor function, and common exclusions include post-stroke seizures, major cognitive or sensory deficits, and contraindications to DBS or MRI.
Why it matters
Potential benefit: If successful, this approach could reduce limb spasticity and improve functional movement, allowing patients to gain more from rehabilitation.
How similar studies have gone: Stimulation of the dentate nucleus/DRTt for post-stroke spasticity is relatively novel with only small case series and pilot reports suggesting benefit, while deep brain stimulation is an established treatment for other movement disorders.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * One time stroke that occurred 9-36 months ago * Ischemic or hemorrhagic stroke * Spastic paresis of at least one limb * At least 3 months of poststroke rehabilitation in the past * No improvement of spasticity/motor function for at least 3 months Exclusion Criteria: * Seizures after the stroke * Depression * Severe sensory deficits * Anosognosia * Moderate to severe hemispatial neglect * Others contraindications for the DBS procedure, e.g. coagulopathy, decompensated chronic disease, etc. * Contraindication for MRI * No poststroke rehabilitation
Where it's running
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Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University
Bydgoszcz, Poland Recruiting
Study contacts
- Study coordinator: Paweł Sokal, Ph.D.
- Email: pawel.sokal@cm.umk.pl
- Phone: +48600954415
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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.