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Recruiting
NCT07738432
Neuro-MoD: Neuroplasticity With Motor Development
Conditions: Perinatal Brain Injury
Sex: All
Ages: 8 Months – 24 Months
Healthy volunteers: No
Phase: NA
Enrollment: 8
Sponsor: University of Wisconsin, Madison
Location: University of Wisconsin - Madison Madison Wisconsin
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.
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
Source: ClinicalTrials.gov (NCT07738432). StuddyBuddy aggregates publicly available trial information.