RecruitingNot Applicable

Epidural Electrical Stimulation in Spinal Cord Injury

China10 participantsStarted 2025-03-01

Plain-language summary

The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function Reconstruction in chronic spinal cord injury (SCI) patients classified as ASIA B-D. The main questions it aims to answer are: Does EES treatment significantly improve motor and sensory function in patients with SCI compared to baseline? Is EES a safe intervention for this patient population? Researchers will compare participants' motor function, sensory function, and quality of life assessments before EES implantation, immediately after activation of the device, and at 1, 3, and 6 months post-implantation to evaluate the longitudinal effects of EES. Participants will: Undergo surgical implantation of an EES device in the epidural space. Have the EES device activated and receive personalized stimulation parameter adjustments during follow-up visits. Complete regular motor and sensory function assessments using standardized protocols. Participate in structured rehabilitation training sessions while using the EES device. Report any adverse events and complete quality of life questionnaires at specified follow-up intervals.

Who can participate

Age range16 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Spinal Cord Injury, ASIA B-D; * Spinal cord injury level above T10; * Diagnosed with spinal cord injury for ≥ 8 months and ≤ 36 months; * WISCI II score \< 13; * No significant improvement in motor dysfunction after rehabitation over the past 2 months. * An expected survival period of ≥ 12 months. * Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, cooperate with necessary postoperative rehabilitation training and tests, and assist in follow-up visits. Exclusion Criteria: * Subjects with other severe organic neurological diseases, mental illnesses other than anxiety/depression. * Subjects with hemorrhagic diathesis or coagulation dysfunction (prothrombin time \[PT\] ≥ 18 seconds). * Subjects with a history of alcohol or drug abuse or dependence. * Subjects with mental retardation, cognitive dysfunction, or personality disorders. * Subjects with a history of electroconvulsive therapy or those requiring continuous electrotherapy. * Subjects with implanted cardiac pacemakers, cardioverters, or defibrillators. Expected survival period \< 1 year.

What they're measuring

WISCI II (Walking Index for Spinal Cord Injury II)

Timeframe: baseline, and 1, 3, 6 monthes after surgery

Functional Independence Measure (FIM)

Timeframe: baseline, and 1, 3, 6 months after surgery

Trial details

NCT IDNCT07105878

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Junming Zhu, Chief Physician

13968055768 dr.zhujunming@zju.edu.cn