N/A
N=20
Perinatal Stroke: Understanding Brain Reorganization
Stroke · Hemiparesis
Bottom Line
View on ClinicalTrials.gov: NCT02743728 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Cortical Excitability MEP Amplitude (µV) — 325 µV
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Magnetic Resonance Imaging (Device); Transcranial Magnetic Stimulation (Device); General Movement Assessment (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cortical Excitability MEP Amplitude (µV) |
325 | — |
| PRIMARY Cortical Excitability Percentage of Maximum |
70 | — |
| SECONDARY General Movement Assessment |
8; 4 | — |
| SECONDARY Adverse Events |
— | — |
| SECONDARY Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) |
46; 42; 38 | — |
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.
Eligibility Criteria
Inclusion Criteria for Pilot Study:
- Birth diagnosis of unilateral perinatal stroke by cranial ultrasound, computer tomography (CT) or magnetic resonance imaging (MRI)
- Corrected gestational age between 3 and 24 months of age for both infants with stroke and typically developing infants
Exclusion Criteria for Pilot Study :
- Metabolic Disorders
- Neoplasm
- Disorders of Cellular Migration and Proliferation
- Acquired Traumatic Brain Injury
- Received surgeries that may constraint current spontaneous movements
- Indwelling metal or incompatible medical devices
- Received surgeries that may constraint current spontaneous movements
- Other neurologic disorders unrelated to stroke
- Small for gestational age (SGA): Infants are smaller in size than normal for the gestational age
- Apneic episodes and syncope (known heart defects) for the safety of participants in the stud.
- Genetic disorders
- Uncontrolled seizures
Additional Inclusion Criteria for Follow-up Study:
- Previous participation in pilot study
Additional Exclusion Criteria for Follow-up Study:
- Lack of wireless internet access or computer to participate in virtual Zoom call
Data sourced from ClinicalTrials.gov (NCT02743728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.