Epidural Electrical Stimulation in Spinal Cord Injury (T11-L3)
Key facts
- Where
- Hangzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 65 years old?
Source: NCT07207798, who can take part
Where in China
- Second Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhou, ChinaContact: Zhoule ZhuTaking people
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
- NCT07207798
- Record updated
- 6 October 2025
- Original description
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 (SCI) at levels T11-L3, classified as ASIA B-D. The study aims to address the following key questions: Does EES lead to significant improvement in motor and sensory function compared to baseline in this patient population? To assess the longitudinal effects of EES, researchers will compare participants' motor function, sensory function, and quality of life measures at multiple time points: prior to EES implantation, immediately after device activation, and at 1, 3, and 6 months post-implantation. Participants will be required to:Undergo surgical implantation of an EES device in the epidural space. Have the device activated and receive individualized stimulation parameter adjustments during follow-up visits. Complete regular motor and sensory 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 predetermined intervals.Read full original descriptionShow less
Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury (T11-L3)
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 (SCI) at levels T11-L3, classified as ASIA B-D. The study aims to address the following key questions: Does EES lead to significant improvement in motor and sensory function compared to baseline in this patient population? To assess the longitudinal effects of EES, researchers will compare participants' motor function, sensory function, and quality of life measures at multiple time points: prior to EES implantation, immediately after device activation, and at 1, 3, and 6 months post-implantation. Participants will be required to:Undergo surgical implantation of an EES device in the epidural space. Have the device activated and receive individualized stimulation parameter adjustments during follow-up visits. Complete regular motor and sensory 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 predetermined intervals.
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 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).