Post-stroke spastic hemiparesis / Post-stroke limb motor dysfunction
Conditions
Interventions
Single-arm cerebellar–spinal interface combined intervention group:Dentate nucleus - spinal cord deep brain stimulation
Sponsors
The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18–70 years; 2. Diagnosis of ischemic or hemorrhagic stroke confirmed by CT or MRI, with a stable primary lesion, disease duration of =6 months, and no significant functional improvement after =6 months of conventional rehabilitation; 3. Post-stroke upper-limb motor dysfunction or spastic hemiparesis, defined as an upper-extremity Fugl-Meyer Assessment score =42, a Modified Ashworth Scale score =2 in the affected limb, and muscle strength = grade 1 in the main muscle groups of the paretic limb; 4. Preserved partial muscle contraction in the affected limb, such as slight finger movement or wrist flexion/extension; 5. Mini-Mental State Examination score =26, without significant cognitive impairment, and able to understand and perform the scheduled rehabilitation tasks; 6. No contraindications to implantation, such as epilepsy, metal allergy, or severe spinal deformity; 7. Life expectancy >1 year; 8. Adequate family or caregiver support; 9. Ability and willingness to comply with all study requirements, complete all required preoperative assessments, commit to =12 months of follow-up, and cooperate with postoperative rehabilitation training and home visits; 10. Willingness to undergo implantation of deep brain stimulation and spinal cord stimulation devices and to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe aphasia, sensory aphasia, or impaired comprehension; 2. Definite diagnosis of other neurodegenerative diseases, such as Alzheimer’s disease or Parkinson’s disease; 3. History of epilepsy or post-stroke epileptic seizures; 4. Complete interruption of the motor pathway with no residual muscle contraction in the affected limb; 5. Severe spasticity or joint contracture, defined as a Modified Ashworth Scale score =3, that may interfere with the effect of electrical stimulation; 6. Presence of other implanted electronic devices that may interfere with DBS and/or SCS; 7. Coagulation dysfunction, INR >1.5, or platelet count 160/100 mmHg or diabetes mellitus with HbA1c >9%; severe cardiopulmonary dysfunction, such as NYHA class III–IV heart failure or COPD GOLD stage 3–4; 8. Unhealed fracture, severe arthritis, or joint replacement in the paretic limb; 9. Severe spinal deformity; 10. Immunosuppression or active infection, such as HIV infection, syphilis, or chronic osteomyelitis; 11. Severe depression, HAMD =17, or history of psychiatric disorders; 12. Pregnancy or planned pregnancy; 13. Life expectancy <1 year; 14. Participation in another clinical trial that may interfere with the results of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Upper Extremity Fugl-Meyer Assessment, FMA-UE;MAS;WMFT;MAL;SIS;EQ-5D-3L;MEP;SSEP;Quantified grip-force curve; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean range and changes of effective SCS treatment parameter windows under DN-DBS short-term on, off, and long-term on conditions.; | — |
Countries
China
Contacts
Public ContactHuanguang Liu
The First Affiliated Hospital of Wannan Medical University (Yijishan Hospital)
Outcome results
None listed