Spinal implant helps paralyzed patients walk again?

NCT ID NCT06965127

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a fully implanted nerve stimulator can help people with incomplete spinal cord injury walk farther and more independently. Five participants will first be screened, then receive the implant and use it for up to two years. The device is turned on and off to compare walking ability with and without stimulation.

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 5 people

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

Started

Aug 2025

Expected to finish

Aug 2031

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

18 to 75 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: * Between the ages of 18-75 * Non-ventilator dependent paralysis resulting from injuries such as: cervical/thoracic spinal cord injuries affecting the trunk and/or lower limbs * Impairment classification of AIS B, C, or D (preservation of sensation and/or some motor function) with weakness in trunk and/or lower extremity muscles * Unable to walk faster than 0.8m/s during a 10m walk test * Gait deviation such as reduced peak hip, knee, and/or ankle range of motion during stance or swing phases due to motor impairment * Time post injury greater than six months * Innervated and excitable lower extremity and trunk musculature * Adequate social support and stability * Willingness to comply with follow-up procedures * Appropriate body habitus (height and weight within acceptable limits as determined by study physician) * Neurologically stable as determined by a physician Exclusion Criteria: * Significant fracture risk or history of spontaneous fractures * History of heterotopic ossification at the hip, knee, or ankle * Non-English speaking * Insufficient upper extremity function to use an assistive device (e.g. walker or cane) * Females who are pregnant * Current pressure injury that would be exacerbated by study activities * Uncontrolled spasticity that would interfere with study activities * Significant range of motion limitations that would compromise study activities * History of vestibular dysfunction, balance problems, or spontaneous falls * Disorder or condition that require MRI monitoring * Acute and/or untreated orthopedic issues that would prevent weight bearing or exercising implanted muscles such as a dislocation or fracture * Acute and/or chronic medical problems left untreated or not controlled that would increase risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise * Uncontrolled diabetes or hypertension * Presence of a demand pacemaker, cardiac defibrillator, or neuroprosthesis system with components in the legs * Any other medical or psychological condition that would be a contraindication Implant eligibility criteria • In addition to all of the above, the participant must be able to fully support their body weight in standing with an assistive device prior to implantation.

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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

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  1. The places running it

    1 site. 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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Louis Stokes Cleveland Veterans Affairs Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

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