Deep Anterior Cerebellar Stimulation in Treatment of Poststroke Spasticity and Motor Function Impairment.

Recruiting now · Not applicable

Conditions studied: Post Stroke Spasticity, Dystonia

In brief

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.

Key facts

Study ID

NCT07190092

Run by

Jan Biziel University Hospital No 2 in Bydgoszcz

People needed

12

Starts

2024-09-01

Expected to finish

2028-12-30

Last updated by the study team

2025-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University — Bydgoszcz, Poland (enrolling)

Full record on ClinicalTrials.gov

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