Recruiting

taVNS & CIMT

Sponsor:

University of Wisconsin, Madison

Code:

NCT07738432

Conditions

Perinatal Brain Injury

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Constraint-Induced Movement Therapy (CIMT)

Transcutaneous auricular vagus nerve stimulation (taVNS)

Study Details

Brief summary:

This study is for infants and toddlers between 8 and 24 months old who use one arm and/or hand differently following a perinatal brain injury. This is a time when investigators think they can best help improve how the brain controls movement. Investigators are testing whether the combination of transcutaneous auricular vagus nerve stimulation (taVNS) with 40 hours of constraint-induced movement therapy (CIMT) can help infants move their weaker arm and hand better and make the brain pathways for movement stronger.

Conditions

Perinatal Brain Injury

Study ID

NCT07738432

Start date

Oct, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Infants and Toddlers with Perinatal Brain Injury

Therapy sessions in this study will take 4 hours a day, 5 days a week for 2 weeks (40 hours total CIMT). Sticker like sensors (electrodes) are placed just inside and outside the child's left earlobe at the start of the session to deliver the taVNS. During daily therapy sessions, the taVNS will be on whenever the child moves their free arm, for up to 2.5 minutes at a time.

Interventions

Constraint-Induced Movement Therapy (CIMT)

CIMT involves placing a mitt constraint on the stronger arm and hand while encouraging your child to use the weaker arm and hand during intensive therapy sessions.

Transcutaneous auricular vagus nerve stimulation (taVNS)

Stimulates a nerve by the ear, called the vagus nerve, that may enhance learning motor skills.

Primary outcome measure

  • Proportion of participants in whom MEPs can be elicited reliably at baseline (presence/absence) [ Time Frame: baseline (Day 1) ]
  • Completion rate of spTMS sessions [ Time Frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up ]

Central Contacts and Locations

Central contacts

Bernadette Gillick, PhD, MSPT

608-262-7457bgillick@wisc.edu

Arun Karumattu Manattu, PhD

608-381-2699karumattuman@wisc.edu

Locations

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Bernadette Gillick, PhD, MSPT

608-262-7457bgillick@wisc.edu

Principal Investigator:

Bernadette Gillick, PhD, MSPT

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Oct 19, 2026

Last verified

Jul, 2026

Keywords

  • hypoxic-ischemic encephalopathy (HIE)
  • perinatal stroke
  • intracranial hemorrhage
  • hemiplegic cerebral palsy (CP)
  • Constraint-Induced Movement Therapy (CIMT)
  • transcutaneous auricular vagus nerve stimulation (taVNS)
  • motor-evoked potentials (MEPs)
  • Single Pulse Transcranial Magnetic Stimulation (spTMS)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.