CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Magnetic Resonance Imaging +2 moredevice
Likely dose
Not stated in record
Key inclusion· 2
  • Birth diagnosis of unilateral perinatal stroke confirmed by cranial ultrasound, CT, or MRI
  • Corrected gestational age between 3 and 24 months
Key exclusion· 11
  • Metabolic disorders
  • Neoplasm
  • Disorders of cellular migration and proliferation
  • Acquired traumatic brain injury

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02743728
NCT02743728N/ACompleted

Perinatal Stroke: Understanding Brain Reorganization Through Infant Neuroimaging and Neuromodulation

University of Minnesota·observational·Posted Apr 19, 2016·Updated Sep 19, 2022

In Brief

An observational study evaluating Magnetic Resonance Imaging, Transcranial Magnetic Stimulation, and 1 other intervention for Stroke and Hemiparesis. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The incidence of perinatal stroke is relatively common, as high as 1 in 2,300 births, but little is known about the resulting changes in the brain that eventually manifest as cerebral palsy (CP). Motor signs that indicate the infant is beginning to develop CP often do not become evident for several months after the diagnosis of perinatal stroke which delays therapy. The main purpose of this study is to examine early brain reorganization in infants 3-12 months of age corrected for prematurity with perinatal stroke using magnetic resonance imaging (MRI) and non-invasive transcranial magnetic stimulation (TMS). In addition, the association between the brain reorganization and motor outcomes of these infant participants will be identified. In this study, the MRI scans will include diffusion tensor imaging (DTI) - an established method used to investigate the integrity of pathways in the brain that control limb movement. Infants will be scanned during nature sleeping after feeding. The real scanning time will be less than 38 minutes. TMS is a painless, non-surgical brain stimulation device which uses principles of electromagnetic induction to excite cortical tissue from outside the skull. Using TMS as a device to modulate and examine cortical excitability in children with hemiparetic CP and in adults has been conducted previously. In this infant study, we will assess cortical excitability from the motor cortex of both the ipsilesional and contralesional hemispheres under the guidance of a frameless stereotactic neuronavigation system. Additionally, the investigators will assess infants' movement quality using an age-appropriate standardized movement assessment. This will allow the investigators to examine the relationship between measures of motor pathway integrity and early signs of potential motor impairment. We will longitudinally follow enrolled infants, and complete repeat assessments at 12- and 24-months corrected age to assess how infants develop over time after perinatal stroke. The remote follow-up will occur at 5 years or less.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 19, 2016
Enrollment StartMay 1, 2016
Primary CompletionJul 31, 2021
Study CompletionJul 31, 2022
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 10.2 years ago

Interventions

Magnetic Resonance Imagingdevice

Anatomical and Diffusion Tensor Imaging Analysis.

Transcranial Magnetic Stimulationdevice

Assessment of brain (cortical) excitability

General Movement Assessmentbehavioral

Spontaneous movement assessment of infant while lying in unperturbed state.