[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597819":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":28,"locations":38,"responsibleParty":58,"collaborators":21,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":21,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":21,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":40,"whyStopped":21,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Medical University of South Carolina","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"sTMS with taVNS paired CIMT","EXPERIMENTAL","sTMS diagnostic testing will be performed before and after 40hours of taVNS paired with CIMT treatment",[13,14],"Device: sTMS","Device: taVNS",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","sTMS","Single pulses of TMS will be delivered over the motor cortex to quantify and map the motor evoked potentials",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"taVNS","taVNS will be used to stimulate the auricular branch of the vagus nerve and paired with CIMT for a total of 40hours of CIMT",[9],[27],"transcutaneous auricular vagus nerve stimulation",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":21,"email":33},"Dorothea Jenkins, MD","CONTACT","843-792-2112","jenkd@mus.edu",{"name":35,"role":31,"phone":36,"phoneExt":21,"email":37},"Cynthia Dodds, PT PhD","843- 792-5731","doddscb@musc.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Charleston","South Carolina","29425","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-79.93275,32.77632,{"lat":50,"lon":49},[53,55],{"name":30,"role":31,"phone":32,"phoneExt":21,"email":54},"jenkd@msuc.edu",{"name":56,"role":57,"phone":21,"phoneExt":21,"email":21},"Cynthia Dodds, PhD PT","SUB_INVESTIGATOR",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Dorothea Jenkins","Professor of Pediatrics","100597819","stms-combined-with-cimt-and-tavns-in-infants-with-hemiplegia-100597819",false,"NCT07063446","sTMS Combined With CIMT and taVNS In Infants With Hemiplegia","Integrating Corticospinal Tract Assessment Via sTMS And taVNS-Augmented CIMT In Infants With Hemiplegia","Inclusion Criteria:\n\n* Infants 8-24mo with hemiplegia or asymmetric weakness of one arm, with or without truncal and transitional motor delays\n* Gross Motor function Classification system (GMFCS) I - IV\n* Parents are able to make consecutive appointments for assessments and intervention over 2wks and complete the 3mo follow-up.\n* Parents are willing to fill out developmental questionnaires and provide the study team feedback on tolerability and outcomes.\n\nExclusion Criteria:\n\n* previous CIMT within 3 months\n* GMFCS V or severe motor impairment\u002Fquadriplegia\n* uncorrected blindness\u002Fdeafness, cardiomyopathy\n* poorly controlled seizure disorder","ALL","8 Months","24 Months",{"count":73,"type":74},10,"ESTIMATED","INTERVENTIONAL",[77],"NA","Preterm and term infants with brain injury frequently have delayed motor skills, and one hand and arm may become stronger than the other, which can signal early cerebral palsy. A new treatment, transcutaneous vagus nerve stimulation (taVNS), boosts specific brain circuits and may improve function when paired with intensive motor activities. This study will test taVNS-paired constraint induced movement therapy in infants who have greater weakness on one side and determine if a single pulse of transcranial brain stimulation over the motor area can cause a measurable movement of the hand or thumb, and indicate which infants can benefit from 40h taVNS-paired CIMT.",[80,81],"Hemiplegia","Perinatal Brain Injury",[83,84,23,18,85],"constraint induced movement therapy","infants","hemiplegia","2025-11-20",{"date":88,"type":89},"2025-11-26","ACTUAL",{"date":91,"type":89},"2025-11-07",{"date":93,"type":74},"2026-12-31",{"name":5,"class":6},1]