Perinatal Brain Injury
Conditions
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)
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.
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
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.
DEVICETranscutaneous auricular vagus nerve stimulation (taVNS)
Stimulates a nerve by the ear, called the vagus nerve, that may enhance learning motor skills.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Months to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants in whom MEPs can be elicited reliably at baseline (presence/absence) | baseline (Day 1) | 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 | baseline (Day 1), post-intervention (Day 12), 3 month follow-up | 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
| Measure | Time frame | Description |
|---|---|---|
| Baseline MEP Amplitude | baseline (Day 1), post-intervention (Day 12), 3 month follow-up | 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 | baseline (Day 1), post-intervention (Day 12), 3 month follow-up | 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 | baseline (Day 1), post-intervention (Day 12), 3 month follow-up | 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) | baseline (Day 1), post-intervention (Day 12), 3 month follow-up | 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. |
| Bayley Scales of Infant Development (Bayley-4; Gross Motor subtests) | baseline (Day 1), post-intervention (Day 12), 3 month follow-up | 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. |
| Gross Motor Function Measure (GMFM-88) | baseline (Day 1), post-intervention (Day 12), 3 month follow-up | 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. |
Contacts
CONTACTBernadette Gillick, PhD, MSPT
CONTACTArun Karumattu Manattu, PhD
PRINCIPAL_INVESTIGATORBernadette Gillick, PhD, MSPT
UW School of Medicine and Public Health
Outcome results
None listed