Stroke
Conditions
Interventions
Dual-mode (BurstDR + Tonic) arm:Epidural spinal cord stimulation (SCS) system implantation, followed by 6 months of combined BurstDR and Tonic stimulation: BurstDR is used in daily life, and Tonic is
Tonic arm:Epidural spinal cord stimulation (SCS) system implantation, followed by 6 months of Tonic stimulation. Stimulation parameters are individualized for each patient.
Sponsors
Beijing Tiantan Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. First-ever stroke 1–10 years prior to enrollment. 2. Unilateral infarct located in the internal capsule or basal ganglia, without involvement of the cerebellum, thalamus, or brainstem. 3. Age > 40 years. 4. FMA-UE: score >=1 on at least one of the following items—elbow flexion/extension or finger flexion/extension. 5. Medical and neurological status stable, as determined by history, physical examination, and neurological examination. 6. FMA-UE total 20–50 (inclusive). 7. Brunnstrom stage II or above in the lower limb. 8. Some distal limb motor function present (e.g., elbow flexion/extension or finger movement with FMA-UE >=1). 9. mRS 24.
Exclusion criteria
Exclusion criteria: 1. Primary hemorrhagic stroke or severe hemorrhagic transformation. 2. Any progressive neurological or systemic disease (other than stroke) impairing function of the affected limb. 3. Moderate to severe neglect/anosognosia of the affected limb. 4. Any other disease that may compromise the safety of participation. 5. Pain NRS =5, or severe sensory loss; NIHSS item 8 = 2. 6. Cardioembolic stroke requiring long-term anticoagulation (excluded). 7. Inability to withhold antiplatelet and/or anticoagulant therapy for >=10 days before surgery. 8. Post-stroke seizures or potential risk thereof. 9. Botulinum toxin injection within 4 weeks before treatment or other non-study active rehabilitation during the follow-up to 90 days after SCS activation. 10. Active psychiatric disorders likely to affect outcomes (e.g., psychosis or severe personality disorder). 11. Untreated or inadequately treated depression, i.e., Beck Depression Inventory (BDI) >=20 at admission. 12. Severe spasticity (Modified Ashworth Scale, MAS >3). 13. Diagnosed dementia. 14. Long-term uncontrolled hypertension or history of cardiovascular disease. 15. MRI contraindications, such as implanted metallic/electronic devices. 1`6. Participation in another device/biologic/drug study within 30 days prior to consent. 17. Women of childbearing potential must use acceptable contraception; pregnancy after enrollment leads to exclusion or study discontinuation. 18. Gait abnormalities due to non-stroke causes. 19. Unable to safely undergo SCS implantation. 20. Any condition judged by investigators to compromise adherence or safety (e.g., worsening illness, serious adverse events, poor compliance).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Motion Function; | — |
Countries
China
Contacts
Public ContactJianguo Zhang
Beijing Tiantan Hospital Affiliated to Capital Medical University
Outcome results
None listed