Overview
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.
Eligibility
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.