[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649867":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":32,"locations":21,"responsibleParty":41,"collaborators":21,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":21,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":21,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":70,"whyStopped":21,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":21},{"fullName":5,"class":6},"University of Wisconsin, Madison","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infants and Toddlers with Perinatal Brain Injury","EXPERIMENTAL","Therapy sessions in this study will take 4 hours a day, 5 days a week for 2 weeks (40 hours total CIMT). Sticker like sensors (electrodes) are placed just inside and outside the child's left earlobe at the start of the session to deliver the taVNS. During daily therapy sessions, the taVNS will be on whenever the child moves their free arm, for up to 2.5 minutes at a time.",[13,14],"Behavioral: Constraint-Induced Movement Therapy (CIMT)","Device: Transcutaneous auricular vagus nerve stimulation (taVNS)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"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.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DEVICE","Transcutaneous auricular vagus nerve stimulation (taVNS)","Stimulates a nerve by the ear, called the vagus nerve, that may enhance learning motor skills.",[9],[28],{"name":29,"affiliation":30,"role":31},"Bernadette Gillick, PhD, MSPT","UW School of Medicine and Public Health","PRINCIPAL_INVESTIGATOR",[33,37],{"name":29,"role":34,"phone":35,"phoneExt":21,"email":36},"CONTACT","608-262-7457","bgillick@wisc.edu",{"name":38,"role":34,"phone":39,"phoneExt":21,"email":40},"Arun Karumattu Manattu, PhD","608-381-2699","karumattuman@wisc.edu",{"type":42,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100649867","neuro-mod-neuroplasticity-with-motor-development-100649867",false,"NCT07738432","Neuro-MoD: Neuroplasticity With Motor Development","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)","Inclusion Criteria:\n\n* Infants aged 8 to 24 months, diagnosed with hemiplegia or with an evident unilateral upper-limb weakness due to perinatal brain injury\n* Gross Motor Function Classification System (GMFCS) level I-IV\n* Infants who have not received previous CIMT in the preceding 3 months\n* Able to make consecutive appointments for assessments and intervention over 2 weeks, and complete the 3-month follow-up.\n\nExclusion Criteria:\n\n* GMFCS level V\n* Prior CIMT within the past 3 months\n* Severe motor impairment\u002Fquadriplegic involvement.\n* Uncontrolled seizure disorders, cardiomyopathy, severe congenital malformations,\n* significant sensory impairments, or conditions preventing safe participation in therapy sessions","ALL","8 Months","24 Months",{"count":54,"type":55},8,"ESTIMATED","INTERVENTIONAL",[58],"NA","This study is for infants and toddlers between 8 and 24 months old who use one arm and\u002For 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.",[61],"Perinatal Brain Injury",[63,64,65,66,18,67,68,69],"hypoxic-ischemic encephalopathy (HIE)","perinatal stroke","intracranial hemorrhage","hemiplegic cerebral palsy (CP)","transcutaneous auricular vagus nerve stimulation (taVNS)","motor-evoked potentials (MEPs)","Single Pulse Transcranial Magnetic Stimulation (spTMS)","NOT_YET_RECRUITING","2026-07-27",{"date":73,"type":74},"2026-07-31","ACTUAL",{"date":76,"type":55},"2026-08",{"date":78,"type":55},"2027-06",{"name":5,"class":6}]