Neuro-MoD: Using taVNS and CIMT to help movement in infants with perinatal brain injury
Official title: 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)
Run by University of Wisconsin, Madison · NCT07738432 · Data updated 2026-11-12
This study tests whether a 40-hour program of constraint-induced movement therapy plus transcutaneous auricular vagus nerve stimulation can improve use of the weaker arm in infants aged 8 to 24 months after perinatal brain injury.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Months to 24 Months |
| Sex | All |
| Enrollment | 8 (estimated) |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Status | Recruiting |
| Started | October 2026 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT07738432 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are 8–24 months old with hemiplegia or unilateral upper-limb weakness from perinatal brain injury, GMFCS I–IV, who have not had CIMT in the past 3 months and can complete a 2-week intervention with a 3-month follow-up.
✕Probably not a fit
Children with GMFCS V, recent CIMT within 3 months, or severe medical conditions that preclude safe therapy may be less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study targets infants and toddlers 8 to 24 months old who have unilateral upper-limb weakness due to perinatal brain injury. Researchers will apply transcutaneous auricular vagus nerve stimulation (taVNS) paired with a 40-hour course of constraint-induced movement therapy (CIMT) to see if this approach strengthens brain pathways controlling the weaker arm. The primary objective is to assess feasibility of eliciting motor-evoked potentials with spTMS and to determine if baseline MEPs predict response to the taVNS-CIMT intervention. An exploratory objective will examine longitudinal neuroplastic changes in cortical motor circuitry alongside motor function. The study is conducted at the University of Wisconsin–Madison and is led by the lead sponsor there, focusing on infants who have not recently received CIMT.
Why it matters
Potential benefit: If successful, the approach could improve use of the weaker arm and strengthen movement-control pathways in young children with perinatal brain injury.
How similar studies have gone: Prior work in neuroplasticity and CIMT in young children suggests potential for improvement, but combining taVNS with CIMT in this age group is exploratory.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Wisconsin - Madison
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Bernadette Gillick, PhD, MSPT — UW School of Medicine and Public Health
- Study coordinator: Bernadette Gillick, PhD, MSPT
- Email: bgillick@wisc.edu
- Phone: 608-262-7457
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.