[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440318":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":35,"centralContacts":39,"locations":44,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":10,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Wisconsin, Madison","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infants",null,"Pre-term and term born infants with corrected gestational age between term age and 24 months with radiologically-confirmed acute unilateral or bilateral brain lesions, including perinatal stroke, neonatal hemorrhagic or thrombotic stroke, involving the motor cortex and\u002For subcortical structures, and intracranial hemorrhage, involving the motor cortex and\u002For subcortical white matter, or periventricular leukomalacia. Parents\u002Flegal guardians able to attend study visits at the University of Wisconsin-Madison.",[13,14,15],"Device: Magnetic Resonance Imaging","Behavioral: Behavioral Assessments","Device: Non invasive Transcranial Magnetic Stimulation",[17,24,29],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DEVICE","Magnetic Resonance Imaging","3 Tesla Discovery MR750 MRI scanner (GE Healthcare, Waukesha, WI) will be used to perform structural imaging, diffusion MRI, relaxometry and microstructural imaging. The exact scan length and parameters of each scan type (T1, T2, DWI) will be set for this study to optimize the quality of data and decrease the length of scanning session for each type of scan. All of the imaging methods have been previously implemented at UW-Madison. Each sequence will take approximately 5-10 minutes.",[9],[23],"MRI",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"BEHAVIORAL","Behavioral Assessments","The behavioral assessments (GMA: General Movements Assessment; HINE: Hammersmith Infant Neurological Examination; Baby Observation of Selective Control AppRaisal (BabyOSCAR); Bayley-4 \u002F Bayley Scales of Infant and Toddler Development 4th ed; Pediatric Evaluation of Disability Inventory -Computer Adaptive Test (PEDI-CAT)) are infant and age-specific and will be administered by trained pediatric occupational and physical therapists.",[9],{"type":18,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Non invasive Transcranial Magnetic Stimulation","TMS will be used to assess cortical excitability and circuitry (not as a neuromodulation intervention). Single-pulse TMS (Magstim 200², Magstim, UK) with a scalp surface coil will be used to assess how the brain is developing and how connected the tract is, between the brain and a target muscle on the arm. 10-20 TMS stimulation pulses will be delivered at a range of stimulation intensities (50-100%) increasing by 5% maximal stimulator output (MSO) at each stage. After this assessment, a brief assessment of peripheral nerve excitability will be performed. Peripheral stimulation will begin at 40% MSO. Stimulation intensity will be adjusted in increments of 5% until motor responses are evident on the EMG. Once motor responses are identified, 10 pulses will be delivered at the stimulation intensity that produced the response. In sum, around 150 stimulation pulses per hemisphere of brain stimulation and 22-60 pulses of peripheral stimulation are expected for TMS assessment of each infant.",[9],[34],"TMS",[36],{"name":37,"affiliation":5,"role":38},"Bernadette Gillick, PhD, MSPT","PRINCIPAL_INVESTIGATOR",[40],{"name":37,"role":41,"phone":42,"phoneExt":10,"email":43},"CONTACT","608-262-3079","bgillick@wisc.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":10},"University of Wisconsin School of Medicine and Public Health","RECRUITING","Madison","Wisconsin","53705","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-89.40123,43.07305,{"lat":57,"lon":56},{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[62],{"name":63,"class":64},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100440318","baby-brain-recovery-study-100440318",false,"NCT05013736","Baby Brain Recovery Study","Perinatal Stroke: Longitudinal Assessment of Infant Brain Organization and Recovery Through Neuroexcitability, Neuroimaging and Motor Development","Main Inclusion Criteria:\n\n* Infants with corrected gestational age between term age and 24 months of age at study enrollment\n* Radiologically-confirmed acute unilateral or bilateral brain lesions, including perinatal stroke, neonatal hemorrhagic or thrombotic stroke, involving the motor cortex and\u002For subcortical structures, and intracranial hemorrhage, involving the motor cortex and\u002For subcortical white matter, periventricular leukomalacia, and hypoxic-ischemic encephalopathy (HIE)\n* English-speaking parent\u002Flegal guardian (able to provide consent)\n\nMain Exclusion Criteria:\n\n* Other neurologic disorders unrelated to perinatal stroke\u002Fbrain bleed\u002FHIE\n* Metabolic disorders\n* Disorders of Cellular Migration and Proliferation\n* Acquired Traumatic Brain Injury","ALL","0 Years","24 Months",{"count":76,"type":77},65,"ESTIMATED","OBSERVATIONAL","This study will be a longitudinal multiple-visit observational study, done to identify possible bioindicators of recovery and repair of motor corticospinal pathways which may be targeted by future interventions in infants with perinatal stroke.\n\n65 participants will be recruited and complete 1 visit at time point 1 (0-2 months), and 2 visits at each timepoints 2-5 with windows of +- 4 weeks (3-6 months, 12 months, 18 months and 24 months). Visits will consist of Magnetic Resonance Imaging (MRI) assessment during the child's natural sleep, Transcranial Magnetic Stimulation (TMS), and Motor Behavioral Assessments.",[81],"Perinatal Stroke",[83,84,85,86,87,88,89,90,91,92,93],"Magnetic Resonance Imaging (MRI)","Brain Reorganization","Brain Lesions","perinatal stroke","neonatal hemorrhagic stroke","neonatal thrombotic stroke","neonatal intracranial hemorrhage","neonatal periventricular leukomalacia","hypoxic ischemic encephalopathy","neonatal brain bleed","early brain injury","2026-01-07",{"date":96,"type":97},"2026-01-08","ACTUAL",{"date":99,"type":97},"2022-07-26",{"date":101,"type":77},"2026-09",{"name":5,"class":6},1]