Epidural electrical stimulation for restoring motor and sensory function after chronic 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 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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

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