Epidural electrical stimulation to restore walking after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 16 and 70 years.
* Diagnosed with traumatic spinal cord injury for ≥ 6 months and ≤ 60 months.
* American Spinal Injury Association Impairment Scale (AIS) grade B-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 it's running

• Second Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Junming Zhu — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Junming Zhu, Chief Physician
• Email: dr.zhujunming@zju.edu.cn
• Phone: 0571-87784716

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.