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Ear stimulation may boost brain rewiring in babies with brain injury

NCT ID NCT07738432

Disease control Sponsor: University of Wisconsin, Madison Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study tests whether combining a gentle nerve stimulation device worn on the ear (taVNS) with intensive arm therapy (CIMT) can help infants and toddlers (8–24 months) with perinatal brain injury improve movement in their weaker arm and hand. The therapy involves placing a mitt on the stronger arm to encourage use of the weaker one during 40 hours of sessions, while the ear stimulation may enhance learning. Researchers will check if this approach is feasible and whether it strengthens brain pathways for movement, with follow-up at 3 months.

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 this approach works, it could lead to a new therapy that helps infants with brain injuries gain better use of their weaker arm and hand, potentially improving their motor development and independence.
What could go wrong
This is a very small early-stage study (8 participants) focused on feasibility, so it may not show clear benefits. The stimulation and therapy may be difficult for infants to tolerate, and results may not apply to all children with similar injuries.

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.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

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 aged 8 to 24 months, diagnosed with hemiplegia or with an evident unilateral upper-limb weakness due to perinatal brain injury * Gross Motor Function Classification System (GMFCS) level I-IV * Infants who have not received previous CIMT in the preceding 3 months * Able to make consecutive appointments for assessments and intervention over 2 weeks, and complete the 3-month follow-up. Exclusion Criteria: * GMFCS level V * Prior CIMT within the past 3 months * Severe motor impairment/quadriplegic involvement. * Uncontrolled seizure disorders, cardiomyopathy, severe congenital malformations, * significant sensory impairments, or conditions preventing safe participation in therapy sessions

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia cerebral palsy spastic hemiplegic Intracranial Hemorrhages

As listed by the trial registrant

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

Perinatal brain injury

How to take part

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  1. 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 ↗

  2. A doctor treating you

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