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Not yet recruiting NCT07738432

Neuro-MoD: Neuroplasticity With Motor Development

No phase Interventional Perinatal Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Constraint-Induced Movement Therapy (CIMT), Transcutaneous auricular vagus nerve stimulation (taVNS).
Who it may be relevant to
Registry conditions: Perinatal Brain Injury. Basic parameters: 8 months — 24 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Detailed description

Primary Objective • To evaluate the feasibility of using spTMS to elicit motor-evoked potentials (MEPs) in infants with hemiplegic cerebral palsy (CP) due to perinatal brain injury and to determine whether baseline MEP characteristics predict motor response to a 40-hour intervention combining taVNS with CIMT.

Exploratory Objective:

• To investigate neuroplastic changes in cortical motor circuitry associated with taVNS-paired CIMT by examining longitudinal changes in MEP topography and corresponding motor function.

Interventions

  • Behavioral Constraint-Induced Movement Therapy (CIMT)
    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.
  • Device Transcutaneous auricular vagus nerve stimulation (taVNS)
    Stimulates a nerve by the ear, called the vagus nerve, that may enhance learning motor skills.

Primary outcome measures

  • Proportion of participants in whom MEPs can be elicited reliably at baseline (presence/absence) [Time frame: baseline (Day 1)]
  • Completion rate of spTMS sessions [Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up]
Secondary outcome measures (6)
  • Baseline MEP Amplitude [Time frame: 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 [Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up]
  • Change in Quality of Upper Extremity Skills Test (QUEST) score from baseline [Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up]
  • Bayley Scales of Infant Development (Bayley-4; Fine Motor subtest) [Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up]
  • Bayley Scales of Infant Development (Bayley-4; Gross Motor subtests) [Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up]
  • Gross Motor Function Measure (GMFM-88) [Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07738432 · 2026-0790 · Protocol Version 6/17/26 · SMPH/Pediatrics/Dev & Reh Med · ICTR Pilot Award

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗