Spinal implant helps paralyzed patients walk again?
NCT ID NCT06965127
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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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
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Louis Stokes Cleveland Veterans Affairs Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
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Other studies related to the condition(s) this trial covers.
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- Play that trains the brain: exercise plus thinking games may boost Preschoolers' balance and gait
- Implanted nerve stimulator aims to restore walking after spinal injury