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Spinal Neurorehabilitation for Veterans With SCI

NCT07222046 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-29

No results posted yet for this study

Summary

Chronic spinal cord injury (SCI) is a debilitating disorder in Veterans and the broader U.S. population that does not have a cure. Veterans with severe SCI demonstrate permanent loss of sensory and motor function below their injury resulting in decreased quality of life and independence. Recently, electrical spinal neuromodulation has emerged as a potential approach to restore voluntary motor function and locomotion in persons with chronic SCI. However, spinal neuromodulation has yet to translate to clinical use due to small sample sizes in research studies and a lack of information on which patients would benefit. Here, the investigators propose a novel approach to evaluate the priorities and barriers faced by Veterans with SCI to use spinal neuromodulation, understand the neural connections remaining in Veterans with severe SCI, and determine potential functional improvements using non-invasive spinal neuromodulation technology. This research represents the first step towards deploying techniques that could dramatically improve function and quality of life for Veterans with SCI.

Conditions

  • Spinal Cord Injuries

Interventions

DIAGNOSTIC_TEST

Neurophysiological and anatomical testing

All participants will undergo neurophysiological testing (transcranial magnetic stimulation and somatosensory evoked potentials) to determine residual neural connectivity. All participants will also undergo MRI of the spine to evaluate residual neural connections and changes above and below lesion. These values will be compared to the standard clinical evaluation of spinal cord injury (ISNCSCI exam).

DEVICE

Transcutaneous Spinal Stimulation

All participants will undergo spinal neuromodulation through non-invasive transcutaneous spinal stimulation to determine the effects on voluntary motor function, sensation, and activities of daily living.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Jonathan Calvert, MD · Providence VA Medical Center, Providence, RI

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-23
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT07222046 on ClinicalTrials.gov