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

NCT07627516 | Recruiting

• 1 other identifier: 2025-1186
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment (FMA)

  One year

Secondary Outcomes (4)

• Active and passive range of motion (A/PROM)

  One year

• Surface electromyography (sEMG):Mean amplitude

  One year

• Modified Ashworth Scale (MAS)

  One year

• TMS-MEP:Amplitude and Waveform morphology

  One year

Study Arms (1)

spinal cord stimulation group

EXPERIMENTAL

Device: Spinal cord stimulator

Interventions

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.

spinal cord stimulation group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Gao Chen

CONTACT

0571-87784713; d.chengao@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 4, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

CN (1)