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Nerve stimulation boosts hand therapy in infants with brain injury?

NCT ID NCT07063446

Symptom relief Sponsor: Medical University of South Carolina Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 combining a mild nerve stimulation (taVNS) with intensive hand therapy (CIMT) can improve arm function in infants aged 8-24 months who have one-sided weakness due to brain injury. Ten infants will receive 40 hours of therapy over two weeks, and researchers will also use brain stimulation to see which babies might benefit most. The goal is to help babies use their weaker hand better.

What this could mean

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

Active substance
transcutaneous auricular vagus nerve stimulation (taVNS) paired with constraint-induced movement therapy (CIMT)
What this could lead to
If it works, this could point toward a new way to improve hand and arm function in infants with one-sided weakness after brain injury.
What could go wrong
This is a very small early study with only 10 infants, so results may not apply to all children. The treatment requires many hours of therapy, and it's unknown if the benefits will last.

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 10 people

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

Started

Nov 2025

Expected to finish

Dec 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

8 to 24 months

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: * Infants 8-24mo with hemiplegia or asymmetric weakness of one arm, with or without truncal and transitional motor delays * Gross Motor function Classification system (GMFCS) I - IV * Parents are able to make consecutive appointments for assessments and intervention over 2wks and complete the 3mo follow-up. * Parents are willing to fill out developmental questionnaires and provide the study team feedback on tolerability and outcomes. Exclusion Criteria: * previous CIMT within 3 months * GMFCS V or severe motor impairment/quadriplegia * uncorrected blindness/deafness, cardiomyopathy * poorly controlled seizure disorder

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Conditions

The condition(s) this trial relates to.

hemiplegia

As listed by the trial registrant

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

Hemiplegia Perinatal brain 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

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

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