Actively Recruiting
Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-24
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Epidural Electrical Stimulation (EES) for improving motor and sensory function in people with chronic spinal cord injuries classified as ASIA B-D. The study focuses on whether EES can significantly enhance motor and sensory abilities compared to before treatment and assess the safety of this approach. Participants include adults aged 16 to 60 years with spinal cord injuries above the T10 level that have been present for 8 to 36 months without recent motor improvement. Participants will undergo surgical implantation of the EES device in the epidural space. After implantation, the device will be activated and personalized stimulation settings adjusted over follow-up visits. Alongside EES, participants will receive standard rehabilitation therapies such as physical and occupational therapy for six months. The study includes regular assessments of motor and sensory function and quality of life at baseline, immediately after device activation, and at 1, 3, and 6 months post-surgery. During the study, participants will complete scheduled tests including walking ability scales and independence measures, as well as evaluations of neurological function, muscle tone, pain, and mood using standardized scales. They will also report any adverse events and attend rehabilitation training sessions while using the EES device. Monitoring occurs at multiple timepoints to track changes over six months, with the goal of understanding EES's impact on function and quality of life in spinal cord injury patients.
CONDITIONS
Brief Title
Epidural Electrical Stimulation in Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Spinal Cord Injury classified as ASIA B-D
- Injury level above the T10 vertebra
- Injury diagnosed for at least 8 months and no more than 36 months
- Walking Index for Spinal Cord Injury II (WISCI II) score less than 13
- No significant motor function improvement after rehabilitation in the past 2 months
- Expected survival period of at least 12 months
- Voluntary participation with signed informed consent and ability to comply with rehabilitation and follow-up visits
You will not qualify if you...
- Other severe organic neurological diseases or mental illnesses besides anxiety or depression
- Hemorrhagic conditions or blood clotting problems with prothrombin time 18 seconds or more
- History of alcohol or drug abuse or dependence
- Mental retardation, cognitive dysfunction, or personality disorders
- History of electroconvulsive therapy or need for ongoing electrotherapy
- Presence of implanted cardiac devices like pacemakers or defibrillators
- Expected survival period 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 - 1 week or until discharge
Participants undergo implantation of electrodes for epidural electrical stimulation followed by immediate post-operative care.
1 surgical visit and several immediate post-operative visits
Duration - 6 months
Participants receive epidural electrical stimulation combined with standard rehabilitation therapy to improve motor and sensory function.
Regular visits for therapy sessions and assessments, including baseline and follow-ups at 1, 3, and 6 months
Duration - Up to 6 months after treatment
Participants are monitored through clinical assessments and imaging to evaluate neurological function and recovery after treatment ends.
Visits at 1, 3, and 6 months after surgery for clinical assessments and imaging
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, Chief Physician
Z
Zhoule Zhu, Attending Physician
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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