Epidural electrical stimulation to restore function after T11–L3 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 with chronic T11–L3 spinal cord injury (ASIA B–D) will undergo surgical implantation of an epidural electrical stimulation (EES) device followed by device activation and individualized programming. Outcomes including motor and sensory function and quality of life will be measured at baseline, immediately after activation, and at 1, 3, and 6 months post-implantation using standardized clinical tests, imaging (PET-CT, DTI), and electrophysiology (SEPs). All participants will receive standard rehabilitation alongside EES and regular follow-up for stimulation adjustments and assessments. The protocol targets people 2–24 months post-injury with limited ambulatory ability (WISCI II <13).

Why it matters

Who can join: the full rules

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.

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
• Email: dr.zhujunming@zju.edu.cn
• Phone: 13968055768

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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.