RECRUITING

Baby Brain Recovery Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-26
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05013736

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 24 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Infants with corrected gestational age between term age and 24 months of age at study enrollment
  2. * 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)
  3. * English-speaking parent/legal guardian (able to provide consent)
  1. * Other neurologic disorders unrelated to perinatal stroke/brain bleed/HIE
  2. * Metabolic disorders
  3. * Disorders of Cellular Migration and Proliferation
  4. * Acquired Traumatic Brain Injury

Contacts and Locations

Study Contact

Bernadette Gillick, PhD, MSPT
CONTACT
608-262-3079
bgillick@wisc.edu

Principal Investigator

Bernadette Gillick, PhD, MSPT
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Bernadette Gillick, PhD, MSPT, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-26
Study Completion Date2026-09

Study Record Updates

Study Start Date2022-07-26
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Perinatal Stroke