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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
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.
Stimulates a nerve by the ear, called the vagus nerve, that may enhance learning motor skills.
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.
Time frame: 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.
Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Baseline MEP Amplitude
MEP amplitude will be reported in millivolts (mV), measured from electromyography recordings of the target muscle.
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
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.
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
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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.
Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
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.
Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Bayley Scales of Infant Development (Bayley-4; Gross Motor subtests)
The Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) Gross Motor subtest evaluates gross motor skills, including posture, sitting, crawling, standing, walking, and other age-appropriate movement abilities. 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.
Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Gross Motor Function Measure (GMFM-88)
The Gross Motor Function Measure-88 (GMFM-88) evaluates gross motor function across five domains: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. Items are scored on a 4-point scale and converted to dimension and total scores ranging from 0 to 100. Higher scores indicate better gross motor function and greater ability to perform age-appropriate motor activities.
Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up