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Neuro-MoD: Neuroplasticity With Motor Development
Harnessing Early Neuroplasticity in Infants With Perinatal Brain Injury: A Study of Combined Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) Paired With Constraint Induced Movement Therapy (CIMT) and Transcranial Magnetic Stimulation (TMS)
Who can join
8 Months – 24 Months · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Constraint-Induced Movement Therapy (CIMT) (behavioral)
- Transcutaneous auricular vagus nerve stimulation (taVNS) (device)
Sponsor: University of Wisconsin, Madison · Participants: 8 · Started: 2026-10
Contact the study team
- Bernadette Gillick, PhD, MSPT · Phone: 608-262-7457
- Arun Karumattu Manattu, PhD · Phone: 608-381-2699
Official record on ClinicalTrials.gov — NCT07738432
Locations in the U.S.
| Wisconsin | University of Wisconsin - Madison, Madison |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.