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Exoskeleton walking plus spinal stimulation may help rebuild muscle and bone after paralysis

NCT ID NCT07418398

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study will test whether combining exoskeleton-assisted walking with a mild electrical stimulation to the spinal cord can improve muscle size and bone strength in people with chronic spinal cord injury. Twenty-four participants who have been injured for more than three years and cannot walk will undergo 108 sessions over 36 weeks. The goal is to see if the combination works better than exoskeleton walking alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcutaneous spinal cord stimulation (tSCS) combined with exoskeleton-assisted walking
What this could lead to
If successful, this could point toward a way to improve muscle mass and bone strength in people with spinal cord injury, potentially reducing fracture risk and improving quality of life.
What could go wrong
This is a small early-stage study with only 24 participants, so results may not apply to everyone. The intervention requires many sessions over 36 weeks, and the stimulation may not produce meaningful benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2032

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • James J. Peters VA Medical Center, Bronx, NY

    The Bronx, New York, 10468-3904, United States

  • Kessler Foundation

    West Orange, New Jersey, 07052, United States

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