Epidural electrical stimulation to restore walking after spinal cord injury
Safety and Efficacy of Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury
This study will try epidural electrical stimulation combined with rehabilitation to help people with chronic AIS C–D spinal cord injuries improve their walking ability.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07306052 on ClinicalTrials.gov |
What this trial studies
Participants will receive an implanted epidural electrical stimulation (EES) device followed by a structured, intensive rehabilitation program designed to promote stepping and overground walking. Functional assessments will be done before implantation and at 1, 3, 6, 9, and 12 months after implantation to track changes over time. Primary outcomes include the Walking Index for Spinal Cord Injury II (WISCI II), the 10‑Meter Walk Test, and the 6‑Minute Walk Test, with secondary measures such as ISNCSCI and SCIM III and electrophysiologic/imaging safety monitoring. The trial enrolls people with chronic incomplete traumatic SCI (AIS C–D) and is conducted at the Second Affiliated Hospital, School of Medicine, Zhejiang University in Hangzhou.
Who should consider this trial
Good fit: Ideal candidates are people aged 16–65 with traumatic incomplete SCI (AIS C–D) 6–36 months after injury, injury level above T10, limited walking ability (WISCI II <13), preserved upper‑limb and sitting function, and measurable lower‑limb EMG responses to spinal stimulation.
Not a fit: People with complete injuries (AIS A–B), injuries below T10, inability to produce clear lower‑limb EMG responses, recent major cardiac or stroke events, or who cannot commit to intensive post‑operative rehabilitation are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could improve walking speed, distance, and independence for some people with incomplete chronic spinal cord injury.
How similar studies have performed: Previous studies combining epidural stimulation with intensive rehabilitation have shown promising gains in voluntary movement and stepping for some individuals with incomplete SCI, but outcomes have varied and long‑term benefits remain under study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 16 and 65 years. * Diagnosed with traumatic spinal cord injury for ≥ 6 months and ≤ 36 months. * American Spinal Injury Association Impairment Scale (AIS) grade C-D. * Spinal cord injury level above T10; * Walking Index for Spinal Cord Injury II (WISCI II) score \< 13. * Completion of a standard conventional rehabilitation program prior to enrollment. * Preserved upper limb function sufficient for self-propelling a manual wheelchair. * Sitting balance grade ≥ 1. * Ability to elicit clear electromyographic responses in lower limb muscles (e.g., rectus femoris, biceps femoris, gastrocnemius, tibialis anterior) upon transcutaneous electrical spinal cord stimulation at the T12-L1 vertebral levels. * Willingness to voluntarily participate, and commitment to compliance with all necessary postoperative rehabilitation, assessments, and follow-up visits. Exclusion Criteria: * History of myocardial infarction or stroke within the past 6 months. * Diagnosis of psychiatric disorders with active suicidal ideation or risk. * Current pregnancy or planned pregnancy during the study period. * Bleeding tendency or coagulopathy (prothrombin time ≥18 seconds). * History of alcohol or substance abuse or dependence. * Intellectual disability, cognitive impairment, or personality disorders. * Other chronic medical conditions that may interfere with rehabilitation (e.g., unhealed severe fractures, hepatic or renal failure, severe anemia, etc.). * Implantation of cardiac pacemakers, cardioverters, or defibrillators. * Any other condition deemed inappropriate for participation by the investigators.
Where this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Junming Zhu — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Junming Zhu, Chief Physician
- Email: dr.zhujunming@zju.edu.cn
- Phone: 0571-87784716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.