Overview
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.
Eligibility
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