Tests deep brain stimulation for muscle stiffness after stroke
Tests brain stimulation at different settings in adults with stroke-related stiffness.
Plain-language title generated from the registry record
Registry title: Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.
Key facts
- Where
- Bydgoszcz, PolandSee the site
Where in Poland
- Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus UniversityBydgoszcz, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jan Biziel University Hospital No 2 in Bydgoszcz
- Trial code
- NCT07190092
- Record updated
- 24 September 2025
- Original description
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.Read full original descriptionShow less
Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.
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.
Inclusion: 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: Seizures after the stroke; Others contraindications for the DBS procedure, e.g. coagulopathy, decompensated chronic disease, etc; Depression; Severe sensory deficits; Anosognosia; Moderate to severe hemispatial neglect; Contraindication for MRI; No poststroke rehabilitation.