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Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury
The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function Reconstruction in chronic spinal cord injury (SCI) patients classified as ASIA B-D. The main questions it aims to answer are: Does EES treatment significantly improve motor and sensory function in patients with SCI compared to baseline? Is EES a safe intervention for this patient population? Researchers will compare participants' motor function, sensory function, and quality of life assessments before EES implantation, immediately after activation of the device, and at 1, 3, and 6 months post-implantation to evaluate the longitudinal effects of EES. Participants will: Undergo surgical implantation of an EES device in the epidural space. Have the EES device activated and receive personalized stimulation parameter adjustments during follow-up visits. Complete regular motor and sensory function 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 specified follow-up intervals.
Age
16 - 60 years
Sex
ALL
Healthy Volunteers
No
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Start Date
March 1, 2025
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2026
Last Updated
September 25, 2025
10
ESTIMATED participants
Epidural Electrical Stimulation
PROCEDURE
Standard Rehabilitation Therapy
PROCEDURE
positron emission tomography-computed tomography (PET-CT)
RADIATION
Diffusion Tensor Imaging (DTI)
RADIATION
Somatosensory Evoked Potentials (SEPs)
PROCEDURE
Motor Evoked Potentials (MEPs)
PROCEDURE
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
NCT07386522
NCT06814015
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07364773