MRI for Non-invasive Evaluation of Brain Stress
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|ClinicalTrials.gov Identifier: NCT01898650|
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : April 26, 2019
Craniosynostosis is a birth defect that causes the bones on a baby's head to fuse together earlier than normal. This causes the baby to have an abnormally shaped head. These children are operated on to prevent or treat increased pressure on the brain, allowing for normal development. There is not good evidence of which children with craniosynostosis have increased pressure on the brain. Up to twenty patients with craniofacial abnormalities will be enrolled in this pilot study. The investigators will use a magnetic resonance scanner to obtain several measures of brain metabolism. The investigators will also obtain data which are markers of developmental delay.
The results will also be compared to age and gender matched data from children without craniofacial abnormalities.
There study hypothesis is that patients with craniofacial abnormalities associated with intracranial pressure will have decreased metabolic activity compared to control patients.
|Condition or disease||Intervention/treatment||Phase|
|Craniosynostosis||Other: MR scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||individual participants will serve as their own controls by using affected and unaffected regions of the brain for paired analysis|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||MRI for Non-invasive Evaluation of Brain Stress|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
Experimental: craniofacial abnormalities
Subjects with craniosynostosis or other craniofacial abnormalities associated with ICP who will undergo an MR scan.
Other: MR scan
- N-acetyl aspartate (NAA) concentration [ Time Frame: one year ]NAA is a highly sensitive marker of brain injury.
- Lactate concentration [ Time Frame: one year ]The presence of lactate can indicate compromised metabolism.
- Blood flow and perfusion [ Time Frame: one year ]To be measured with both oxygen extraction fraction and arterial spin labeling to measure blood flow.
- functional connectivity [ Time Frame: one year ]We will measure functional connectivity using an rfcMRI sequence. Functional connectivity is sensitive to developmental delay.
- Intracranial Pressure (ICP) [ Time Frame: 1/1/2015 ]Intracranial Pressure as measured by MR data uses a formula that assesses both cerebral blood flow and the flow of cerebral spinal fluid in to and out of the brainstem.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898650
|United States, Missouri|
|St. Louis Children's Hospital|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Kamlesh Patel, MD||Washington University School of Medicine|