RecruitingNot ApplicableNCT07105878

Epidural Electrical Stimulation in Spinal Cord Injury

Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

10 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injuries (SCI)

Summary

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.

Eligibility

Min Age: 16 YearsMax Age: 60 Years

Inclusion Criteria7

Spinal Cord Injury, ASIA B-D;
Spinal cord injury level above T10;
Diagnosed with spinal cord injury for ≥ 8 months and ≤ 36 months;
WISCI II score < 13;
No significant improvement in motor dysfunction after rehabitation over the past 2 months.
An expected survival period of ≥ 12 months.
Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, cooperate with necessary postoperative rehabilitation training and tests, and assist in follow-up visits.

Exclusion Criteria6

Subjects with other severe organic neurological diseases, mental illnesses other than anxiety/depression.
Subjects with hemorrhagic diathesis or coagulation dysfunction (prothrombin time \[PT\] ≥ 18 seconds).
Subjects with a history of alcohol or drug abuse or dependence.
Subjects with mental retardation, cognitive dysfunction, or personality disorders.
Subjects with a history of electroconvulsive therapy or those requiring continuous electrotherapy.
Subjects with implanted cardiac pacemakers, cardioverters, or defibrillators. Expected survival period < 1 year.

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Interventions

PROCEDUREEpidural 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.

PROCEDUREStandard 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.

RADIATIONpositron 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.

RADIATIONDiffusion 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.

PROCEDURESomatosensory 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.

PROCEDUREMotor 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.