Baby Brain Recovery Study

ConditionPerinatal Stroke

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age0-24

SponsorUniversity of Wisconsin, Madison

About this trial

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.

65 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.

Eligibility criteria

Qualifiers

Infants with corrected gestational age between term age and 24 months of age at study enrollment

Radiologically-confirmed acute unilateral or bilateral brain lesions, including perinatal stroke, neonatal hemorrhagic or thrombotic stroke, involving the motor cortex and/or subcortical structures, and intracranial hemorrhage, involving the motor cortex and/or subcortical white matter, periventricular leukomalacia, and hypoxic-ischemic encephalopathy (HIE)

English-speaking parent/legal guardian (able to provide consent)

Disqualifiers

Other neurologic disorders unrelated to perinatal stroke/brain bleed/HIE

Metabolic disorders

Disorders of Cellular Migration and Proliferation

Acquired Traumatic Brain Injury

Trial design

Treatments tested in this trial

Magnetic Resonance Imaging
Behavioral Assessments
Non invasive Transcranial Magnetic Stimulation

Treatment groups

65 Participants

are divided into 1 treatment group

Sponsors and collaborators

University of Wisconsin, Madison

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov