NCT02743728

Perinatal Stroke: Understanding Brain Reorganization

Completed Results posted Last updated 19 September 2022

What this trial tests

trial testing Magnetic Resonance Imaging in Stroke in 20 participants. Completed in 31 July 2022.

Timeline

1 May 2016

Primary endpoint
31 July 2021

31 July 2022

Quick facts

Lead sponsor	University of Minnesota
Status	Completed
Study type	OBSERVATIONAL
Enrollment	20
Start date	1 May 2016
Primary completion	31 July 2021
Estimated completion	31 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Magnetic Resonance Imaging
• Transcranial Magnetic Stimulation — full drug profile →
• General Movement Assessment

Conditions studied

• Stroke — all drugs for Stroke →
• Hemiparesis — all drugs for Hemiparesis →

Sponsor

University of Minnesota

Who can join

Adults 3 Months to 5, any sex, with Stroke or Hemiparesis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cortical Excitability MEP Amplitude (µV) Primary · 2 hours

Cortical excitability of ipsilesional and contralesional hemispheres assessed by transcranial magnetic stimulation (TMS) in infants with perinatal stroke. TMS will be used to assess cortical excitability through electromagnetic depolarization of targeted cortical neurons through painless pulses delivered over the scalp. The estimated time of TMS assessment is around 2 hours during Visit 2. Outcome is reported as MEP amplitude in units of microvolts (µV).

Group	Value	95% CI
All Infants	325	50 – 500

Cortical Excitability Percentage of Maximum Primary · 2 hours

Cortical excitability of ipsilesional and contralesional hemispheres assessed by transcranial magnetic stimulation (TMS) in infants with perinatal stroke. TMS will be used to assess cortical excitability through electromagnetic depolarization of targeted cortical neurons through painless pulses delivered over the scalp. The estimated time of TMS assessment is around 2 hours during Visit 2. The outcome of motor threshold will be reported as the percentage of maximum stimulator output.

Group	Value	95% CI
All Infants	70	50 – 95

General Movement Assessment Secondary · 15 minutes

Movement quality will be assessed by general movement assessment (GMA). GMA requires 5-10 minutes videotaping when infants are placed in spine position for scoring. Infants are scores categorically as typical (present fidgety movements) or atypical (absent, sporadic, or abnormal fidgety movements). Outcome is reported as the number of typical infants and number of atypical infants.

Group	Value	95% CI
All Infants	8
All Infants	4

Adverse Events Secondary · 2 days

Recording of adverse events will take place during TMS cortical mapping and MRI scanning of infants with perinatal stroke. Assessment of vital signs changes and pain/stress responses during both MRI and TMS assessment during visit 1 and visit 2. Outcome is reported as the number of adverse events recorded.

Group	Value	95% CI
All Infants	0

Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) Secondary · 15 minutes

The PEDI-CAT uses Item Response Theory statistical models to estimate a child's ability from a minimal number of items. Three functional domains will be assessed. The PEDI-CAT software provides normative standard scores presented as T scores and age percentile ranges to assess daily activities, mobility, and social/cognitive function. Outcome is reported as the mean score generated by the PEDI-CAT software. Scores are based on t-test values and do not have a unit of measure or a defined range. Higher scores indicate greater deviation from the standardized mean score.

Daily Activities

Group	Value	95% CI
All Infants	46	1 – 87

Mobility

Group	Value	95% CI
All Infants	42	1 – 78

Social/Cognitive

Group	Value	95% CI
All Infants	38	2 – 62

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Understanding Brain Reorganization in Infants With Perinatal Stroke Through Neuroexcitability and Neuroimaging.
   Chen CY, Georgieff M, Elison J, Chen M, et al · · 2017 · cited 9× · PMID 28350777 · DOI 10.1097/pep.0000000000000365