Recruiting NCT07627516
Clinical Study of the Efficacy and Safety of Spinal Cord Stimulation in Patients With Limb Motor Dysfunction Following Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spinal cord stimulator.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device 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.
Primary outcome measures
- Fugl-Meyer Assessment (FMA) [Time frame: One year]
Secondary outcome measures (4)
- Active and passive range of motion (A/PROM) [Time frame: One year]
- Surface electromyography (sEMG):Mean amplitude [Time frame: One year]
- Modified Ashworth Scale (MAS) [Time frame: One year]
- TMS-MEP:Amplitude and Waveform morphology [Time frame: One year]
Eligibility criteria
Inclusion criteria
- Hemiparesis resulting from a single ischemic or hemorrhagic stroke, with a disease duration of ≥6 months.
- Aged between 20 and 80 years (inclusive).
- 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.
- Partially preserved sensory function.
Exclusion criteria
- 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.
- Presence of spinal cord-related nerve compression that could cause severe functional impairment.
- Women who are pregnant or breastfeeding.
- Use of anticoagulant, antiplatelet, antispasmodic, or antiepileptic medications prior to enrollment or during the study period.
- Severe joint contracture that, in the clinical investigator's opinion, precludes participation in the study.
- Severe mental illness or intellectual disability that prevents cooperation with treatment or follow-up questionnaires, with a Mini-Mental State Examination (MMSE) score <24.
- Presence of other implanted medical devices.
- Severe claustrophobia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07627516 · 2025-1186