Status:
RECRUITING
Epidural Electrical Stimulation in Spinal Cord Injury (T11-L3)
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
College of Biomedical Engineering and Instrumentation Science, Zhejiang University
Conditions:
Spinal Cord Injuries (SCI)
Eligibility:
All Genders
16-65 years
Phase:
NA
Brief Summary
The primary objective of this clinical trial is to investigate the efficacy of Epidural Electrical Stimulation (EES) in restoring motor and sensory function in patients with chronic spinal cord injury...
Eligibility Criteria
Inclusion
- Spinal Cord Injury, ASIA B-D;
- Spinal cord injury levels at T11-L3;
- Diagnosed with spinal cord injury for ≥ 2 months and ≤ 24 months;
- WISCI II score \< 13;
- 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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07207798
Start Date
July 1 2025
End Date
December 30 2026
Last Update
October 6 2025
Active Locations (1)
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1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009