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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID: NCT07418398
Run by: VA Office of Research and Development
People needed: 24
Starts: 2026-11-01
Expected to finish: 2032-11-01
Last updated by the study team: 2026-07-22

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Non-walkers with an SCI greater than 3 years post injury
As measured by a member of the study staff, participants who have a lower extremity motor score greater or equal to 16 on the INSCSCI exam with an impairment grade of C or D
Neurologic level of injury as determined by study staff between C5-T10 (completed at participant's screening)
Capable of gripping Lofstrand crutches and/or a walker without assistance
Wheelchair reliant 100% of the time
Height is between 62 inches and 74 inches
Weight less than 220lbs
Anthropometric compatibility with the EAW device:
Thigh length between 14 and 19 in (36 and 48 cm)
Shank length between 17 and 22 in (43 and 55 cm)

You may not qualify if…

As determined by the study physician from the screening health exam, a history of fragility or traumatic fractures, unhealed fractures, and signs of swelling, bruising, and discoloration of the legs
Current bone disease diagnosis (e.g., osteomyelitis, hyperparathyroidism)
As determined by the study physician from the screening DXA study, a T-score at the total hip < -3.5 or aBMD of the knee (proximal tibia and/or distal femur) < 0.60 g/cm2 from the DXA screen
Positive pregnancy test at any of the study intervention or assessment visits, or if female participants plan to become pregnant over the course of the study, they will be excluded or withdrawn (if already enrolled) from participation
Currently in a gym/rehabilitation program performing ambulatory interventions such as EAW, as determined by the study staff
Currently prescribed any medications that can affect muscle and/or bone metabolism, as determined by the study staff
Exclusion Criteria from MRI Safety Screening:
Medically unsafe to receive an MRI scan
Claustrophobia
Baclofen pump
Body metal, including any of the following:
metal fragments or pieces in eyes or any other part of body
pacemakers or other implanted electrical devices
aneurysm clips (metal clips on wall of a large artery)
metallic prostheses (metal pins and heart valves)
internal hearing aids (cochlear implants)
permanent eyeliner
shrapnel fragments
piercing that cannot be removed

Where it is running

Kessler Foundation — West Orange, New Jersey, United States
James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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