Post-stroke limb motor impairment (chronic hemiparesis)
Conditions
Interventions
Single arm:All participants undergo implantation of bilateral dentate nucleus DBS leads and an implantable pulse generator (IPG). Initial programming is performed about 4 weeks postoperatively. Contra
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Imaging confirms unilateral ischemic or hemorrhagic stroke, with a duration of >=6 months and <=10 years since onset, and the condition has been relatively stable for the past month; 2. Age 18–80 years; 3. Unilateral hemiplegia as the main deficit, baseline FMA total score 10–50 points; 4. mRS <=3, no severe aphasia or serious cognitive impairment, able to cooperate with assessment and follow-up; 5. MRI shows no extensive cerebellar/brainstem damage; DTI indicates DRTT not completely severed; 6. Able to complete at least 6 months of follow-up and complete rehabilitation and examinations as required; 7. Subject or legally authorized representative signs informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe swallowing disorder or repeated aspiration/inhalation pneumonia; 2. Extensive bilateral cerebellar lesions, or the dentate nucleus/superior cerebellar peduncle/DRTT directly damaged by the lesion; 3. Surgical/anesthesia contraindications (severe cardiopulmonary insufficiency, uncontrolled hypertension, coagulation disorders, etc.); 4. Uncontrolled psychiatric disorders or severe cognitive impairment; 5. Pregnancy/lactation or planning pregnancy during the study period; 6. Other active implanted devices that may interfere with DBS and cannot ensure compatibility; 7. Repeated generalized seizures in the past 6 months or combined with other severe neurological diseases; 8. Severe internal medical comorbidities (active tumor, severe liver or renal failure, etc.); 9. Currently or recently participating in other clinical trials that may interfere with results; 10. Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total Fugl–Meyer Assessment motor score (?FMA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Ashworth Scale (MAS) score for spasticity/muscle tone (upper and lower limbs);FMA domain/subscores (UE/LE; proximal/distal; coordination/balance);Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) score;Hospital Anxiety and Depression Scale (HADS) total and subscale scores (HADS-A/HADS-D);Visual Analog Scale (VAS) score for pain/discomfort (0–10);Short Form-36 Health Survey (SF-36) domain scores; | — |
Countries
China
Contacts
Public ContactChangqing Liu
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed