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Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation: Effect on Imaging and Serum Biomarkers of Skeletal Muscle Mass and Bone Strength.

NCT07418398 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-07-22

No results posted yet for this study

Summary

Immobilization following spinal cord injury (SCI) results in muscle and bone loss below the level of injury, which ultimately predisposes to fracture at several sites throughout the legs and can lead to several medical complications that can devastate quality of life. There is a scarcity of research that has successfully implemented rehabilitation and/or exercise training interventions to preserve the musculoskeletal system during the acute phase SCI, or possibly reverse the muscle and bone loss that has already occurred in chronic SCI. This study will compare the effect of exoskeleton-assisted walking (EAW) training combined with transcutaneous spinal cord stimulation (tSCS) (EAW + active tSCS), to that of EAW + sham tSCS, on measures of muscle and bone health in a cohort of chronically injured motor incomplete SCI. A successful outcome would expand treatment options to improve musculoskeletal health over the lifetime.

Conditions

Interventions

DEVICE

Exoskeleton-Assisted Walking (EAW)

Participants will perform EAW will for 60 minutes per session for a total of 108 sessions (3 X week for 36 weeks).

DEVICE

Sham Transcutaneous Spinal Cord Stimulation (tSCS)

The lumbosacral tSCS electrical signal is set too low to have any biological effect while simultaneously performing EAW.

DEVICE

Active Transcutaneous Spinal Cord Stimulation (tSCS)

Participants in the active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Chris Cirnigliaro, MS · James J. Peters Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-01
Primary Completion
2030-11-01
Completion
2032-11-01
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 NCT07418398 on ClinicalTrials.gov