Actively Recruiting
Deep Anterior Cerebellar Stimulation for Poststroke Spasticity and Motor Function Impairment
Led by Jan Biziel University Hospital No 2 in Bydgoszcz · Updated on 2025-09-24
12
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether deep brain stimulation (DBS) can improve rehabilitation and functional recovery in patients with post-stroke spasticity. The study aims to find out if DBS is effective and which stimulation frequency works best. Participants are adults who have experienced a stroke and have persistent spasticity despite prior rehabilitation. Participants will undergo surgery to implant a DBS electrode targeting the dentate-rubro-thalamic tract near the dentate nucleus of the cerebellum on the side affected by spasticity. They will receive stimulation at three different frequencies: 130 Hz, 70 Hz, and 30 Hz, each followed by a 4- to 6-week rehabilitation program. After each rehabilitation period, participants return for clinical evaluations to assess the effects of the stimulation frequency. Throughout the study, patients will be evaluated using clinical scales such as the Fugl-Meyer Assessment (FMA), Ashworth Scale, Motor Assessment Scale (MAS), and Modified Rankin Scale to measure improvements in motor function and spasticity. The study includes follow-up visits after each stimulation period, with a total participation duration covering the three rehabilitation cycles. Researchers will compare outcomes at different frequencies to understand the clinical impact of DBS on post-stroke spasticity.
CONDITIONS
Brief Title
Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- One-time stroke that occurred 9 to 36 months ago
- Ischemic or hemorrhagic stroke diagnosis
- Spastic weakness in at least one limb
- At least 3 months of post-stroke rehabilitation completed
- No improvement in spasticity or motor function for at least 3 months prior to enrollment
You will not qualify if you...
- Seizures after the stroke
- Depression
- Severe sensory deficits
- Anosognosia
- Moderate to severe hemispatial neglect
- Contraindications for DBS procedure such as coagulopathy or decompensated chronic disease
- Contraindication for MRI
- No prior post-stroke rehabilitation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo implantation of deep brain stimulation electrodes targeting the dentate nucleus of the cerebellum under general anesthesia, followed by immediate post-operative care.
1 visit (in-person)
Duration - 4 weeks per treatment arm
Participants receive different stimulation settings via implanted deep brain stimulation electrodes: high-frequency, low-frequency, or no stimulation (sham). Each treatment phase lasts four weeks with assessments at the beginning and end.
2 visits (start and end of each treatment phase)
Trial Site Locations
Total: 1 location
1
Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University
Bydgoszcz, Poland, 85-168
Actively Recruiting
Research Team
P
Paweł Sokal, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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