Clinical Study of the Efficacy and Safety of Spinal Cord Stimulation in Patients With Limb Motor Dysfunction Following Stroke

Zhejiang University

Status: Enrolling

Conditions: Stroke

Treatments: Device: Spinal cord stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT07627516

2025-1186

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

spinal cord stimulation group

Experimental group

Treatment:

Device: Spinal cord stimulator