Epidural electrical stimulation for restoring motor and sensory function after chronic spinal cord injury

Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury

This will try epidural electrical stimulation to see if it helps people with chronic spinal cord injuries (ASIA B–D) regain motor and sensory function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 16 Years to 60 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07105878 on ClinicalTrials.gov

What this trial studies

Participants will undergo surgical implantation of an epidural electrical stimulation (EES) device with device activation and personalized stimulation adjustments during follow-up. Motor and sensory function, plus quality of life, will be measured before implantation, immediately after activation, and at 1, 3, and 6 months post-implantation. The protocol includes standard rehabilitation and objective testing such as PET-CT, diffusion tensor imaging (DTI), and somatosensory evoked potentials (SEPs) to track physiological changes. Eligible patients are chronic SCI cases (8–36 months post-injury) with ASIA B–D and injury level above T10.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic spinal cord injury 8–36 months after injury, ASIA impairment scale B–D, injury above T10, limited improvement after rehabilitation, and a WISCI II score below 13.

Not a fit: Patients with injuries outside the 8–36 month window, injuries at or below T10, severe other neurological or psychiatric disorders, coagulation dysfunction, or active substance dependence may not benefit or may be excluded.

Why it matters

Potential benefit: If successful, EES could restore some voluntary movement and sensation and improve independence and quality of life for people with chronic SCI.

How similar studies have performed: Prior case series and small trials of epidural stimulation have produced notable voluntary movement and functional gains in some patients, but larger controlled evidence remains limited.

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.

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, Chief Physician — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Junming Zhu, Chief Physician

Conditions Spinal Cord Injuries; Epidural Electrical Stimulation; Sensor function reconstruction; Motor function reconstruction