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Exoskeletal Walking and Spinal Cord Stimulation for Spinal Cord Injury

This study is looking at how exoskeleton-assisted walking (EAW) combined with transcutaneous spinal cord stimulation (tSCS) affects muscle and bone health in people with chronic spinal cord injury (SCI). You would participate in walking sessions using an exoskeleton. Some participants will also receive active tSCS, which is a mild electrical stimulation to the spine, while others will receive a sham (inactive) tSCS. Researchers want to see if these treatments can help reverse muscle and bone loss that often happens after an SCI. The main goal is to measure changes in muscle size in your mid-thigh. This study is for non-walkers with an SCI that happened more than three years ago, between the ages of 21 and 60. There are 24 participants planned for this study, but the current recruitment status is unclear.

Study design
This is an interventional study with 24 planned participants. It compares exoskeleton-assisted walking with active transcutaneous spinal cord stimulation to exoskeleton-assisted walking with sham (inactive) transcutaneous spinal cord stimulation.
What's involved
You would perform exoskeleton-assisted walking for 60 minutes per session, three times a week for 36 weeks, totaling 108 sessions. Muscle measurements will be taken at the beginning of the study and again after 9 months.
Compensation
Not stated in the trial record.
Follow-up
Muscle cross-sectional area will be measured at the start of the study and again at the 9-month mark after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07418398

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

Not Yet Recruiting
NAAges 21–60InterventionalTreatment
VA Office of Research and Development
~24 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Exoskeleton-Assisted Walking (EAW)Sham Transcutaneous Spinal Cord Stimulation (tSCS)Active Transcutaneous Spinal Cord Stimulation (tSCS)

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Muscle cross sectional area of the mid-thigh
Measured over Obtained prior to starting the study at enrollment (baseline) and again at the 9 month study time point (post intervention).

Conditions

Spinal Cord Injury

Explore related trials

Spinal Cord Injury

Where it's being run

2 sites across 2 states
New Jersey1
New York1

Study leadership

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

Who to contact

Chris Cirnigliaro, MS
[email protected]
(973) 731-3900 · ext. 2755
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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
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

What this trial measures

  • Muscle cross sectional area of the mid-thighObtained prior to starting the study at enrollment (baseline) and again at the 9 month study time point (post intervention).

    EAW + active tSCS will increase muscle cross sectional area of the mid-thigh more than EAW + sham tSCS.