Observing brain recovery in infants with perinatal stroke
Perinatal Stroke: Longitudinal Assessment of Infant Brain Organization and Recovery Through Neuroexcitability, Neuroimaging and Motor Development
University of Wisconsin, Madison · NCT05013736
This study is trying to find signs of brain recovery in babies who had a stroke before or during birth to see how their brains develop and how early help can improve their outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 0 Years to 24 Months |
| Sex | All |
| Sponsor | University of Wisconsin, Madison (other) |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05013736 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify bioindicators of recovery in infants who have experienced perinatal stroke by conducting multiple visits over two years. Participants will undergo Magnetic Resonance Imaging (MRI) during natural sleep, Transcranial Magnetic Stimulation (TMS), and motor behavioral assessments at various developmental stages. The study focuses on understanding brain reorganization and the potential for early interventions to improve outcomes for these infants. By mapping the development of motor corticospinal pathways, researchers hope to enhance early diagnosis and prognosis of conditions like cerebral palsy.
Who should consider this trial
Good fit: Ideal candidates are infants aged between term age and 24 months with confirmed brain lesions related to perinatal stroke.
Not a fit: Patients with other unrelated neurological disorders or metabolic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early interventions and better long-term outcomes for infants affected by perinatal stroke.
How similar studies have performed: While there is limited understanding of brain recovery post-perinatal stroke, similar studies using neuroimaging and non-invasive stimulation have shown promise in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Main Inclusion Criteria: * 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) Main Exclusion Criteria: * Other neurologic disorders unrelated to perinatal stroke/brain bleed/HIE * Metabolic disorders * Disorders of Cellular Migration and Proliferation * Acquired Traumatic Brain Injury
Where this trial is running
Madison, Wisconsin
- University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Bernadette Gillick, PhD, MSPT — University of Wisconsin, Madison
- Study coordinator: Bernadette Gillick, PhD, MSPT
- Email: bgillick@wisc.edu
- Phone: 608-262-3079
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Perinatal Stroke, Magnetic Resonance Imaging, Brain Reorganization, Brain Lesions, perinatal stroke, neonatal hemorrhagic stroke, neonatal thrombotic stroke, neonatal intracranial hemorrhage