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Can painless spinal zaps teach injured kids to walk again?

NCT ID NCT04077346

Symptom relief Sponsor: University of Louisville Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether transcutaneous spinal stimulation, a non-invasive technique that sends mild electrical pulses through the skin, can help children with chronic spinal cord injury take steps. The study enrolls 8 children ages 4 to 12 who cannot stand or walk on their own. Participants receive stimulation alongside activity-based locomotor training, and researchers measure muscle activity, joint movement, and whether children can take an independent step.

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 stimulation using the Biostim-5 stimulator, combined with activity-based locomotor training
What this could lead to
If it works, this approach could offer children with spinal cord injury a way to take steps with less support, and it could guide future neuromodulation treatments for kids.
What could go wrong
This is a very small, early study of 8 children, so results may not apply broadly. Spinal stimulation carries risks like skin irritation or discomfort, and stepping ability may not improve for every participant.

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 8 people

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

Started

Apr 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

4 to 12 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: * Children with acquired, upper motor neuron (T10 and above) SCI, traumatic and non-traumatic, * Chronic injury, defined as greater than one year post injury * Age 4-12 years, * Discharged from inpatient rehabilitation, * Unable to stand, walk, or initiate steps. Exclusion Criteria: * Botox use within past 3 months * Current oral baclofen use, * Baclofen pump in use, * Musculoskeletal impairment limiting range of motion, unhealed fracture or other medical complication limiting participation, * Prior surgery for scoliosis, post SCI * Congenital SCI, * Total ventilator dependence. For Aim 3, additional exclusionary criteria are: * Unwilling or unable to wean from baclofen during training, * Use of braces (trunk or lower limb brace).

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Conditions

The condition(s) this trial relates to.

Gait Disorders, Neurologic spinal cord injury

As listed by the trial registrant

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

Spinal cord injuries

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Department of Neurosurgery, University of Louisville

    Louisville, Kentucky, 40202, United States

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