Epidural Electrical Stimulation in Spinal Cord Injury
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Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 60 years old?
Source: NCT07105878, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07105878
- Record updated
- 24 April 2026
- Original description
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:Read full original descriptionShow less
Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury
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.
Inclusion: 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: Subjects with other severe organic neurological diseases, mental illnesses other than anxiety/depression; 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; Subjects with hemorrhagic diathesis or coagulation dysfunction (prothrombin time [PT] ≥ 18 seconds).