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

Not Applicable

Recruiting

• Conditions: Post Stroke Spasticity; Dystonia

• Registration Number: NCT07190092
• Lead Sponsor: Jan Biziel University Hospital No 2 in Bydgoszcz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-01
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Primary Completion: 2027-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Increase of FMA score after the rehabilitation with stimulation dentate-rubro-thalamic tract.	6 weeks	Increase of FMA score after the rehabilitation

Secondary Outcome Measures

Name	Time	Method
Decrease of Ashworth Scale score after the rehabilitation with dentate-rubro-thalamic tract	6 weeks	Decrease of Ashworth Scale score
Improvement in motor function achieves in Motor Assessment Scale MAS with stimulation dentate-rubro-thalamic tract	6 weeks	Improvement in motor function achieves in Motor Assessment Scale
Improvement in Modified Rankin Scale after the rehabilitation with stimulation of dentato-rubro-thalamic tract	6 weeks	Improvement in Modified Rankin Scale

Trial Locations

Locations (1)

Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University; 🇵🇱 Bydgoszcz, Poland