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Can spinal stimulation plus intense training help children injured at birth move better?

NCT ID NCT06808035

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers at the University of Louisville are studying children who have a cervical spinal cord injury that happened before or during birth. The study combines activity-based recovery training, which uses tasks like stepping and standing, with transcutaneous spinal cord stimulation, a non-invasive method that sends electrical signals through the skin. Up to 6 children will receive 40 sessions of this combined therapy, with assessments before, during, and after to track changes in movement, nerve function, and daily tasks. The goal is to understand how this approach affects whole-body function in this rare group.

What this could mean

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

Active substance
activity-based recovery training combined with transcutaneous spinal cord stimulation
What this could lead to
If it works, this approach could help children with spinal cord injuries from birth gain better movement and everyday function. It could also shape how doctors tailor rehabilitation for each child.
What could go wrong
This is a very small study of 6 children, so results may not apply broadly. The training is intensive and requires many sessions, and some children may not improve or may have limited response.

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 6 people

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

Started

Jan 2024

Expected to finish

Jan 2027

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

3 to 8 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: * diagnosed with a perinatal (injured in utero or at birth), upper motor neuron spinal cord injury involving cervical spinal levels * discharged from inpatient hospitalization/inpatient rehabilitation Exclusion Criteria: * Botox use within the past 3 months * Current oral baclofen or baclofen pump use * Musculoskeletal impairment limiting range of motion (e.g. severe scoliosis), unhealed fracture, or other medical impairment limiting study participation * History of allodynia (heightened skin sensitivity typically at the level of the lesion site) * History of scoliosis surgery * Ventilator-dependence * Unwillingness to wean from daytime use of thoroco/lumbosacral orthosis and ankle/foot orthosis during the intervention period

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

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

Perinatal spinal cord injury

How to take part

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

  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.

    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

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States