Stroke
Conditions
Brief summary
To assess the efficacy and safety of spinal cord stimulation in treating post-stroke limb motor disorders, we propose to conduct a clinical trial. This study seeks to accumulate additional clinical experience with spinal cord stimulation in patients suffering from post-stroke limb motor disorders and to enhance their quality of life.
Interventions
DEVICESpinal cord stimulator
This trial is a single-arm, self-controlled exploratory clinical study. Participants will undergo surgical implantation of spinal cord stimulation electrodes and receive programming and optimization of spinal cord stimulation parameters.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Hemiparesis resulting from a single ischemic or hemorrhagic stroke, with a disease duration of ≥6 months. 2. Aged between 20 and 80 years (inclusive). 3. Received regular rehabilitation therapy after stroke but with poor recovery of limb motor function; Fugl-Meyer Assessment upper extremity score \>7 and \<45, and lower extremity score \>5 and \<30. 4. Partially preserved sensory function.
Exclusion criteria
1. Severe systemic diseases (e.g., neurological disorders other than stroke, cancer, severe circulatory or respiratory diseases, liver or kidney failure, etc.) or other conditions that may impair the subject's motor or cognitive function. 2. Presence of spinal cord-related nerve compression that could cause severe functional impairment. 3. Women who are pregnant or breastfeeding. 4. Use of anticoagulant, antiplatelet, antispasmodic, or antiepileptic medications prior to enrollment or during the study period. 5. Severe joint contracture that, in the clinical investigator's opinion, precludes participation in the study. 6. Severe mental illness or intellectual disability that prevents cooperation with treatment or follow-up questionnaires, with a Mini-Mental State Examination (MMSE) score \<24. 7. Presence of other implanted medical devices. 8. Severe claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment (FMA) | One year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Active and passive range of motion (A/PROM) | One year | — |
| Surface electromyography (sEMG):Mean amplitude | One year | Mean surface electromyography (sEMG) amplitude, measured in microvolts (µV), will be derived from recordings of lower-limb muscles, including the tibialis anterior, gastrocnemius, quadriceps femoris, and biceps femoris. Recordings will be obtained during standardized lower-limb motor tasks or voluntary muscle contractions. Measurements will be analyzed separately for each muscle and, where applicable, for each side. This parameter will be used to assess changes in lower-limb muscle activation after spinal cord stimulation. Higher values indicate greater muscle activation. |
| Modified Ashworth Scale (MAS) | One year | The Modified Ashworth Scale (MAS) will be used to assess muscle tone and spasticity in lower-limb muscle groups, including hip flexors, hip extensors, hip adductors, hip abductors, knee flexors, knee extensors, ankle plantar flexors, and ankle dorsiflexors. MAS grades range from 0 to 4, with an additional intermediate grade of 1+. For statistical analysis, MAS grades may be converted to a 0-5 ordinal score, where 0 indicates no increase in muscle tone and 5 indicates that the affected limb is rigid in flexion or extension. Higher scores indicate greater muscle tone and more severe spasticity. Scores will be assessed separately for each side and compared across baseline and follow-up assessments. |
| TMS-MEP:Amplitude and Waveform morphology | One year | Motor evoked potential (MEP) amplitude and waveform morphology will be assessed from transcranial magnetic stimulation-induced MEP recordings of lower-limb muscles, including the tibialis anterior, gastrocnemius, quadriceps femoris, and biceps femoris. MEP amplitude will be measured as the peak-to-peak amplitude, measured in microvolts (µV) or millivolts (mV), according to the study protocol. The presence, reproducibility, and morphology of the MEP waveform will also be evaluated. Measurements will be analyzed separately for each muscle and, where applicable, for each side. These parameters will be used to evaluate changes in corticospinal excitability and motor pathway function after spinal cord stimulation. |
Countries
China
Contacts
CONTACTGao Chen
Outcome results
None listed