Stroke
Conditions
Interventions
Tonic arm:Patients will undergo implantation of an epidural spinal cord stimulation (SCS) lead, followed by 6 months of Tonic-mode stimulation. Stimulation parameters will be individualized for each p
Sponsors
Beijing Tiantan Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Between 1 and 10 years after first stroke; 2. Unilateral infarction located in the internal capsule or basal ganglia region, without involvement of the cerebellum, thalamus, or brainstem; 3. Age over 40 years; 4. Score >=1 on at least one of the following FM-UE subscales: elbow flexion, elbow extension, or finger flexion/extension; 5. Medical and neurological status deemed stable by the investigator based on medical history, physical examination, and neurological assessment; 6. FMA-UE score between 20 and 50 (inclusive); 7. Lower limb Brunnstrom stage II or higher; 8. Some motor function present in distal limbs (elbow flexion, elbow extension, or FMA-UE score for fingers >=1); 9. mRS 24.
Exclusion criteria
Exclusion criteria: 1. Primary hemorrhagic stroke or severe hemorrhagic transformation; 2. Any progressive neurological or physical disease other than stroke that impairs function of the affected limb; 3. Moderate to severe neglect or inattention in the affected limb; 4. Any other condition that may reduce the safety of study participation; 5. Pain intensity in the affected limb with NRS >=5, or severe sensory impairment, NIHSS (item 8) = 2 points; 6. Exclusion of cardioembolic stroke in patients requiring long-term anticoagulation therapy; 7. Inability to discontinue anticoagulation (i.e., antiplatelet and/or anticoagulant agents) for at least 10 days prior to surgery; 8. Post-stroke seizures or potential risk of seizures; 9. Receipt of botulinum toxin injection or other non-study-related active rehabilitation therapies within 4 weeks before treatment and up to 90 days after SCS initiation; 10. Active psychiatric illness that may affect treatment efficacy, such as psychosis or severe personality disorder; 11. Untreated or inadequately treated depression, defined as a Beck Depression Inventory score >=20 at admission; 12. Severe spasticity (MAS >3); 13. Diagnosis of dementia; 14. Longstanding uncontrolled hypertension or history of cardiovascular disease; 15. MRI contraindications, such as implanted metallic or electronic devices; 16. Participation in another device, biological, or drug study within 30 days prior to informed consent for the current study; 17. Non-pregnant women of childbearing potential must use acceptable contraception; pregnancy excludes or terminates study participation; 18. Gait abnormality due to causes other than stroke; 19. Inability to safely implant the SCS device; 20. The investigator deems the patient has a condition that significantly increases risk to study adherence, safety, or subject well-being. From a subject safety perspective, this includes situations such as disease progression, serious adverse events, or poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Motion Function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Wolf Motor Function Test (WMFT) Score;Change in Action Research Arm Test (ARAT) Score; | — |
Countries
China
Contacts
Public ContactZhang Jianguo
Beijing Tiantan Hospital Affiliated to Capital Medical University
Outcome results
None listed