Actively Recruiting
Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury (T11-L3)
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-10-06
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
C
College of Biomedical Engineering and Instrumentation Science, Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of Epidural Electrical Stimulation (EES) to help restore motor and sensory function in people with chronic spinal cord injuries at levels T11 to L3, classified as ASIA B-D. The study aims to determine if EES improves motor and sensory abilities compared to before treatment and will also evaluate changes in quality of life over time. This clinical trial is sponsored by the Second Affiliated Hospital, School of Medicine, Zhejiang University. Participants will undergo surgery to have an EES device implanted in the epidural space of the spine. After implantation, the device will be activated and personalized stimulation settings will be adjusted during follow-up visits. Participants will also engage in ongoing structured rehabilitation therapy, including physical and occupational therapies, over a period of six months while using the device. Throughout the study, participants will complete regular motor and sensory assessments using standard measures such as the Walking Index for Spinal Cord Injury II (WISCI II) and the Functional Independence Measure (FIM) at baseline and at 1, 3, and 6 months after surgery. Other evaluations include neurological classification, muscle tone, pain scales, and mental health assessments. Participants will report any side effects and complete quality-of-life questionnaires during scheduled visits. The entire study participation lasts at least six months post-implantation.
CONDITIONS
Brief Title
Epidural Electrical Stimulation in Spinal Cord Injury (T11-L3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Spinal cord injury classified as ASIA B-D
- Injury located at levels T11 to L3
- Diagnosed with spinal cord injury for at least 2 months and no more than 24 months
- Walking Index for Spinal Cord Injury II (WISCI II) score less than 13
- Expected survival of at least 12 months
- Willing to voluntarily participate, sign informed consent, comply with postoperative rehabilitation and tests, and assist with follow-up visits
You will not qualify if you...
- Presence of other severe neurological diseases or mental illnesses other than anxiety or depression
- Hemorrhagic diathesis or coagulation dysfunction with prothrombin time equal to or greater than 18 seconds
- History of alcohol or drug abuse or dependence
- Mental retardation, cognitive dysfunction, or personality disorders
- History of electroconvulsive therapy or need for continuous electrotherapy
- Implanted cardiac devices such as pacemakers, cardioverters, or defibrillators
- Expected survival less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive Epidural Electrical Stimulation combined with standard rehabilitation therapy, including physical and occupational therapy, to improve motor and sensory function.
Visits at baseline, and 1, 3, and 6 months after surgery
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
J
Junming Zhu
Z
Zhoule Zhu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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