NCT07105878 Epidural Electrical Stimulation in Spinal Cord Injury
| NCT ID | NCT07105878 |
| 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 | 2025-03-01 |
| Primary Completion | 2026-12-31 |
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 2025-03-01 with a primary completion date of 2026-12-31.
⚠ 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 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 Criteria
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.
Contact & Investigator
Junming Zhu, Chief Physician
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT07105878 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 60 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 NCT07105878 currently recruiting?
Yes, NCT07105878 is actively recruiting participants. Contact the research team at dr.zhujunming@zju.edu.cn for enrollment information.
Where is the NCT07105878 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07105878 clinical trial?
NCT07105878 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Junming Zhu, Chief Physician at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 10 participants.