NCT07207798 Epidural Electrical Stimulation in Spinal Cord Injury (T11-L3)
| NCT ID | NCT07207798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Spinal Cord Injuries (SCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-07-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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.
Eligibility Criteria
Inclusion Criteria: * 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 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.
Contact & Investigator
Junming Zhu
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT07207798 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 65 Years, studying Spinal Cord Injuries (SCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07207798 currently recruiting?
Yes, NCT07207798 is actively recruiting participants. Contact the research team at dr.zhujunming@zju.edu.cn for enrollment information.
Where is the NCT07207798 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07207798 clinical trial?
NCT07207798 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Junming Zhu at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 10 participants.