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Epidural Electrical Stimulation in Spinal Cord Injury (T11-L3)
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
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.
Official title: Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury (T11-L3)
Key Details
Gender
All
Age Range
16 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2025-07-01
Completion Date
2026-12-30
Last Updated
2025-10-06
Healthy Volunteers
No
Conditions
Interventions
Epidural Electrical Stimulation
Epidural Electrical Stimulation (EES) is a medical technology that involves delivering controlled electrical impulses to the spinal cord through electrodes implanted in the epidural space-the area between the outermost membrane of the spinal cord (dura mater) and the vertebrae. This technique aims to modulate the activity of spinal neural networks, thereby regulating neurological functions and promoting functional recovery, particularly in individuals with spinal cord injuries or certain neurological disorders.
Standard Rehabilitation Therapy
A structured, multidisciplinary rehabilitation program designed to improve motor function, mobility, and independence in participants with paralysis. The therapy typically includes physical Therapy and occupational Therapy.
positron emission tomography-computed tomography (PET-CT)
PET-CT is an advanced hybrid imaging modality that combines metabolic information from positron emission tomography with anatomical details from computed tomography.
Diffusion Tensor Imaging (DTI)
DTI is an advanced MRI technique that maps white matter tracts by measuring the directionality (anisotropy) and magnitude of water molecule diffusion in neural tissues. It provides quantitative metrics of fibers.
Somatosensory Evoked Potentials (SEPs)
SEPs are electrophysiological responses recorded from the central or peripheral nervous system following electrical stimulation of sensory nerves. They assess the functional integrity of somatosensory pathways.
Motor Evoked Potentials (MEPs)
MEPs are electrophysiological responses elicited by transcranial magnetic stimulation or electrical stimulation of the motor cortex, recorded from peripheral muscles or the spinal cord. They evaluate the integrity of corticospinal tracts.
Locations (1)
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China