Neuro-MoD: Neuroplasticity With Motor Development

NCT07738432 | Not Yet Recruiting FDA Device

• 4 other identifiers: 2026-0790Protocol Version 6/17/26SMPH/Pediatrics/Dev & Reh MedICTR Pilot Award
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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

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)

Outcome Measures

Primary Outcomes (2)

• Proportion of participants in whom MEPs can be elicited reliably at baseline (presence/absence)

  Motor-evoked potentials (MEPs) are electrical responses recorded from a muscle following a brief magnetic pulse delivered to the brain using single-pulse transcranial magnetic stimulation (spTMS). This outcome measures the proportion of participants in whom a reliable MEP can be elicited at baseline and serves as a measure of the feasibility of assessing corticospinal connectivity in infants with perinatal brain injury.

  baseline (Day 1)

• Completion rate of spTMS sessions

  This outcome measures the proportion of planned spTMS assessment sessions that are successfully completed at baseline, post-intervention, and 3-month follow-up. Completion rates will be used to evaluate the feasibility, tolerability, and practicality of conducting repeated spTMS assessments in infants and toddlers with perinatal brain injury.

  baseline (Day 1), post-intervention (Day 12), 3 month follow-up

Secondary Outcomes (6)

• Baseline MEP Amplitude

  baseline (Day 1), post-intervention (Day 12), 3 month follow-up

• Percent change in Mini-Assisting Hand Assessment (mini-AHA) score from baseline to end of treatment

  baseline (Day 1), post-intervention (Day 12), 3 month follow-up

• Change in Quality of Upper Extremity Skills Test (QUEST) score from baseline

  baseline (Day 1), post-intervention (Day 12), 3 month follow-up

• Bayley Scales of Infant Development (Bayley-4; Fine Motor subtest)

  baseline (Day 1), post-intervention (Day 12), 3 month follow-up

• Bayley Scales of Infant Development (Bayley-4; Gross Motor subtests)

  baseline (Day 1), post-intervention (Day 12), 3 month follow-up

Other Outcomes (3)

• MEP Amplitude

  baseline (Day 1), post-intervention (Day 12), 3 month follow-up

• MEP Threshold

  baseline (Day 1), post-intervention (Day 12), 3 month follow-up

• Cortical Map Topography

  baseline (Day 1), post-intervention (Day 12), 3 month follow-up

Study Arms (1)

Infants and Toddlers with Perinatal Brain Injury

EXPERIMENTAL

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)

Interventions

Constraint-Induced Movement Therapy (CIMT) BEHAVIORAL

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.

Infants and Toddlers with Perinatal Brain Injury

Transcutaneous auricular vagus nerve stimulation (taVNS) DEVICE

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

Infants and Toddlers with Perinatal Brain Injury

Eligibility Criteria

• Age: 8 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Intracranial Hemorrhages

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Bernadette Gillick, PhD, MSPT

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernadette Gillick, PhD, MSPT

CONTACT

608-262-7457; bgillick@wisc.edu

Arun Karumattu Manattu, PhD

CONTACT

608-381-2699; karumattuman@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share