Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2026-01-01
Last updated
2026-06-04
Condition(s) studied
Stroke
Investigational drug(s) / intervention(s)
Spinal cord stimulator
Spinal 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.
Study 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.
Eligibility
Sex
ALL
Min age
20 Years
Max age
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.
Primary outcome measure(s)
Fugl-Meyer Assessment (FMA) — One year
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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