Perinatal Stroke: Longitudinal Assessment of Infant Brain Organization and Recovery Through Neuroexcitability, Neuroimaging and Motor Development

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Maximum Age: 2
Healthy Volunteers: f
View:

• 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)

Locations
United States
Wisconsin
University of Wisconsin School of Medicine and Public Health
RECRUITING
Madison
Contact Information
Primary
Bernadette Gillick, PhD, MSPT
bgillick@wisc.edu
608-262-3079
Time Frame
Start Date: 2022-07-26
Estimated Completion Date: 2026-09
Participants
Target number of participants: 65
Treatments
Infants
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/or subcortical structures, and intracranial hemorrhage, involving the motor cortex and/or subcortical white matter, or periventricular leukomalacia. Parents/legal guardians able to attend study visits at the University of Wisconsin-Madison.
Related Therapeutic Areas
Sponsors
Leads: University of Wisconsin, Madison
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov