NCT07190092Recruiting
Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.
Source: ClinicalTrials.gov · Last updated 24 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of this clinical trial is to determine whether deep brain stimulation (DBS) interventions improve rehabilitation and functional recovery in patients with post-stroke spasticity who meet the other inclusion criteria listed below. Primary question(s) to be answered: Is DBS stimulation effective in treating post-stroke spasticity? What stimulation frequency is most effective in treating post-stroke spasticity? Study participants will: * Undergo surgery to implant a DBS electrode targeting the DRTt (dentate-rubro-thalamic tract ) in close proximity of the dentate nucleus of the cerebellum ipsilateral to the spastic side of the body. * Each patient will then receive an initial stimulation frequency of 130 Hz (arm 1) and will be assigned to a 4- to 6-week rehabilitation program. After this period, the participant will return for a follow-up visit for a clinical evaluation. * The frequency will then be changed to 70Hz (arm 2). Patients who have undergone this change will also undergo a rehabilitation period of 4 to 6 weeks. After this period, they will return to the Clinic for a follow-up evaluation. * The frequency will then be changed to 30Hz (arm 3). Patients who have undergone this change will also undergo a rehabilitation period of 4 to 6 weeks. Researchers will compare the results obtained from patients in each arm to determine the clinical effects of stimulation and whether they are dependent on the stimulation frequency.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 1 Sept 2025
- Start date
- 1 Sept 2024
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Jan Biziel University Hospital No 2 in Bydgoszcz
- Diseases
- Stroke
- NCT number
- NCT07190092
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 1 Sept 2024 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Seizures after the stroke
- Others contraindications for the DBS procedure, e.g. coagulopathy, decompensated chronic disease, etc.
Other
- Depression
- Severe sensory deficits
- Anosognosia
- Moderate to severe hemispatial neglect
- Contraindication for MRI
- No poststroke rehabilitation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.