Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury

Summary

The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) combined with rehabilitation training for the reconstruction of walking in patients with chronic spinal cord injury (SCI) classified as AIS C-D. The main questions it aims to answer are:

Does the intervention of EES combined with rehabilitation significantly improve walking capacity? Is the combined intervention a safe approach for this patient population? Researchers will compare participants' functional assessments before EES implantation and at 1, 3, 6, 9, and 12 months post-implantation to evaluate the longitudinal effects. The primary assessments include the Walking Index for Spinal Cord Injury II (WISCI II), the 10-Meter Walk Test (10mWT), and the 6-Minute Walk Test (6minWT). Secondary outcome measures encompass the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), the Spinal Cord Independence Measure (SCIM III), the Functional Independence Measure (FIM), the Modified Ashworth Scale (MAS), the Penn Spasm Frequency Scale, and pain Visual Analogue Scale (VAS) scores. Neurophysiological and imaging evaluations, including electromyography (EMG), motor evoked potentials (MEPs), somatosensory evoked potentials (SEPs), and positron emission tomography-computed tomography (PET-CT), will be conducted preoperatively and at 6 months postoperatively to explore the mechanisms of neuroplasticity.

Participants will:

Undergo surgical implantation of an EES device. Receive personalized EES parameter programming combined with rehabilitation training (≥2 hours daily) post-operatively.

Complete a series of standardized functional and clinical outcome assessments at scheduled follow-up intervals.

Undergo scheduled neurophysiological and metabolic imaging studies. Report any adverse events throughout the study duration.

Conditions

• Spinal Cord Injuries (SCI)

Interventions

PROCEDURE

Epidural spinal cord stimulation

Epidural spinal cord stimulation 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.

PROCEDURE

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.

RADIATION

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.

PROCEDURE

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.

PROCEDURE

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.

RADIATION

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.

Sponsors & Collaborators

• Zhejiang University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Junming Zhu · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-12

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• China

Study Locations