Neuro-MoD: Neuroplasticity With Motor Development | NCT07738432

NCT07738432

Overview

NCT ID: NCT07738432
Lead Sponsor: University of Wisconsin, MadisonOTHER
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)
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Jun 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 8Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Bernadette Gillick, PhD, MSPTContact
bgillick@wisc.edu608-262-7457

Similar Studies

Participant Group/Arms

Infants and Toddlers with Perinatal Brain InjuryExperimental

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.

Behavioral: Constraint-Induced Movement Therapy (CIMT)

Device: Transcutaneous auricular vagus nerve stimulation (taVNS)