Epidural electrical stimulation to restore function after T11–L3 spinal cord injury

Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury (T11-L3)

This study will see if epidural electrical stimulation can help people with chronic T11–L3 spinal cord injuries (ASIA B–D) regain motor and sensory function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 16 Years to 65 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07207798 on ClinicalTrials.gov

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).

Who should consider this trial

Good fit: Ideal candidates are adults with chronic T11–L3 spinal cord injury classified ASIA B–D, 2–24 months post-injury, WISCI II <13, medically fit for surgery and rehabilitation, and able to attend follow-up visits.

Not a fit: Patients unlikely to benefit include those outside the T11–L3 injury levels, with ASIA A complete injuries (not enrolled), severe comorbid neurological or psychiatric conditions, coagulation disorders, implanted cardiac devices, or inability to undergo surgery or rehabilitation.

Why it matters

Potential benefit: If successful, EES could improve voluntary movement, sensation, and overall quality of life for people with mid- to lower-thoracic chronic spinal cord injuries.

How similar studies have performed: Previous small studies of epidural stimulation have shown promising but variable gains in voluntary movement and function, while larger confirmatory trials remain limited.

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.

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

Conditions: Spinal Cord Injuries, Epidural Electrical Stimulation