Neuro-MoD: Neuroplasticity With Motor Development
ConditionPerinatal Brain Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-24
SponsorUniversity of Wisconsin, Madison
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
Qualifiers
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
Treatments tested in this trial
- Constraint-Induced Movement Therapy (CIMT)
- Transcutaneous auricular vagus nerve stimulation (taVNS)
Treatment groups
8 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov