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Neuromodulation Techniques After SCI

NCT04241250 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2026-04-28

Study results available
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Summary

Spinal cord injury (SCI) leads to several health-related consequences often linked to reduced levels of physical activity. Direct stimulation of the spinal cord, either through implanted devices or surface stimulation, has been combined with intense physical therapy assisted treadmill walking to facilitate independent standing and stepping. These current methods require 3-4 highly skilled therapists and may not be feasible in all rehabilitation settings, especially when considering the growing number of SCI patients each year. Therefore, the use of robotic exoskeleton suits combined with direct stimulation of the spinal cord (requiring 1-2 therapists) may offer an alternative rehabilitation approach to overcome their limited abilities to stand and walk. Such improvements may also help to reverse or eliminate other health-related consequences associated with SCI. The pilot work will provide the preliminary evidence required to design future clinical trials for Veterans and civilians with SCI to restore overground mobility.

Conditions

Interventions

DEVICE

EAW+SCES (exoskelton and spinal cord epidural stimulation)

Three months of exoskeleton training followed by 6 months of epidural stimulation.

DEVICE

EAW+TS (exoskelton and transspinal stimulation)

Three months of exoskeleton training followed by 6 months of transspinal stimulation.

Sponsors & Collaborators

  • Virginia Commonwealth University

    collaborator OTHER

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Ashraf Gorgey, PhD PT · Hunter Holmes McGuire VA Medical Center, Richmond, VA

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2024-07-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04241250 on ClinicalTrials.gov