Can spinal stimulation plus intense training help children injured at birth move better?
NCT ID NCT06808035
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
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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 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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3 to 8 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: * 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.
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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University of Louisville
RECRUITINGLouisville, Kentucky, 40202, United States