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NCT02743728 · ClinicalTrials.gov registry record
Perinatal Stroke: Understanding Brain Reorganization
A clinical trial, sponsored by University of Minnesota.
- Completed
- Registry status
- 20
- Enrollment target
NCT02743728: Completed study, sponsored by University of Minnesota.
NCT02743728 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02743728 has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study 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
Primary Outcome
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).
Interventions
- DEVICE Transcranial Magnetic Stimulation
- DEVICE Magnetic Resonance Imaging
- BEHAVIORAL General Movement Assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-05-01 |
| Est. Completion | 2022-07-31 |
What the finished NCT02743728 record still lists
NCT02743728 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Transcranial Magnetic Stimulation is the first listed.
NCT02743728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02743728 about?
NCT02743728 is a clinical study titled "Perinatal Stroke: Understanding Brain Reorganization". 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 ...
What is the current status of trial NCT02743728?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2016-05-01. Estimated completion is 2022-07-31.
What interventions are being tested in trial NCT02743728?
The interventions under investigation include: Transcranial Magnetic Stimulation (DEVICE), Magnetic Resonance Imaging (DEVICE), General Movement Assessment (BEHAVIORAL).
Who is sponsoring clinical trial NCT02743728?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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