Epidural Electrical Stimulation in Spinal Cord Injury (T11-L3)

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.

Conditions

• Spinal Cord Injuries (SCI)

Interventions

PROCEDURE

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.

PROCEDURE

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.

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.

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.

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.

Sponsors & Collaborators

• College of Biomedical Engineering and Instrumentation Science, Zhejiang University

  collaborator UNKNOWN

• 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

2025-07-01

Primary Completion

2026-12-30

Completion

2026-12-30

Countries

• China

Study Locations