About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
GMFCS level V
Prior CIMT within the past 3 months
Severe motor impairment/quadriplegic involvement.
Uncontrolled seizure disorders, cardiomyopathy, severe congenital malformations,
Trial design
Single group
Treatments tested in this trial
Constraint-Induced Movement Therapy (CIMT)
BehavioralCIMT 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.
Transcutaneous auricular vagus nerve stimulation (taVNS)
DeviceStimulates a nerve by the ear, called the vagus nerve, that may enhance learning motor skills.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Baseline MEP Amplitude
MEP amplitude will be reported in millivolts (mV), measured from electromyography recordings of the target muscle.
Percent change in Mini-Assisting Hand Assessment (mini-AHA) score from baseline to end of treatment
The mini-AHA evaluates how effectively infants with unilateral upper extremity impairment use their affected hand during bimanual play activities. Scores are reported on a standardized 0-100 scale, with higher scores indicating greater functional use of the affected hand and lower scores indicating less functional use.
Change in Quality of Upper Extremity Skills Test (QUEST) score from baseline
This is a measure of movement, scored in several domains: dissociated movement (joint mobility), grasp (holding and manipulating objects), protective extension (reflex reactions), and weight bearing assessments. It is scored from 0 to 100 where higher scores mean better movement. Change in QUEST score from baseline will be used to assess changes in upper extremity function following the intervention.
Bayley Scales of Infant Development (Bayley-4; Fine Motor subtest)
The Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) Fine Motor subtest evaluates fine motor skills, including reaching, grasping, object manipulation, and hand-eye coordination. Scores are standardized based on age and range from 1 to 19, with a normative mean of 10 and standard deviation of 3. Scores in the range of 8-12 are generally considered within the typical range for age. Higher scores indicate more advanced motor development.
Other outcomes
MEP Amplitude
Motor-evoked potential (MEP) amplitude measures the strength of the muscle response produced after a brief magnetic pulse is applied to the brain using single-pulse transcranial magnetic stimulation (spTMS). Larger amplitudes indicate stronger communication between the brain and the target muscle. MEP amplitude will be reported in millivolts (mV).
MEP Threshold
Motor-evoked potential (MEP) threshold is the minimum level of magnetic stimulation needed to produce a muscle response. Lower thresholds generally indicate that the pathway between the brain and muscle can be activated more easily. MEP threshold will be reported as a percentage of maximum stimulator output (%MSO).
Cortical Map Topography
Cortical map topography describes the location and distribution of brain areas that produce muscle responses when stimulated using single-pulse transcranial magnetic stimulation (spTMS). Changes in the size, location, or organization of these areas over time may reflect changes in brain connectivity and neuroplasticity.
Locations
Sponsors and contacts
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