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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spinal cord stimulation group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal cord stimulator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment (FMA) | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Active and passive range of motion (A/PROM) | One year | |
| Surface electromyography (sEMG):Mean amplitude | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gao Chen | Contact | 0571-87784713 | d.chengao@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| One year |
| Modified Ashworth Scale (MAS) | 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. | One year |
| TMS-MEP:Amplitude and Waveform morphology | 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. | One year |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |