Actively Recruiting
Epidural Electrical Stimulation 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
78 weeks
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
The primary objective of this clinical trial is to investigate the efficacy of Epidural Electrical Stimulation (EES) in restoring motor and sensory function in patients with chronic spinal cord injury (SCI) at levels T11-L3, classified as ASIA B-D. The study aims to address the following key questions: Does EES lead to significant improvement in motor and sensory function compared to baseline in this patient population? To assess the longitudinal effects of EES, researchers will compare participants' motor function, sensory function, and quality of life measures at multiple time points: prior to EES implantation, immediately after device activation, and at 1, 3, and 6 months post-implantation. Participants will be required to:Undergo surgical implantation of an EES device in the epidural space. Have the device activated and receive individualized stimulation parameter adjustments during follow-up visits. Complete regular motor and sensory assessments using standardized protocols. Participate in structured rehabilitation training sessions while using the EES device. Report any adverse events and complete quality-of-life questionnaires at predetermined intervals.
CONDITIONS
Official 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 spinal levels T11 to L3
- Diagnosis of spinal cord injury between 2 and 24 months ago
- Walking Index for Spinal Cord Injury II (WISCI II) score less than 13
- Expected survival period of at least 12 months
- Willingness to participate voluntarily, sign informed consent, comply with rehabilitation and tests, and attend follow-up visits
You will not qualify if you...
- Presence of other severe organic neurological diseases or mental illnesses aside from anxiety or depression
- Hemorrhagic diathesis or coagulation dysfunction with prothrombin time (PT) ≥ 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
- Having implanted cardiac pacemakers, cardioverters, or defibrillators
- Expected survival period less than 1 year
AI-Screening
AI-Powered Screening
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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
CONTACT
Z
Zhoule Zhu
CONTACT
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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