MRI for Non-invasive Evaluation of Brain Stress
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||MRI for Non-invasive Evaluation of Brain Stress|
- N-acetyl aspartate (NAA) concentration [ Time Frame: one year ] [ Designated as safety issue: No ]NAA is a highly sensitive marker of brain injury.
- Lactate concentration [ Time Frame: one year ] [ Designated as safety issue: No ]The presence of lactate can indicate compromised metabolism.
- Blood flow and perfusion [ Time Frame: one year ] [ Designated as safety issue: No ]To be measured with both oxygen extraction fraction and arterial spin labeling to measure blood flow.
- functional connectivity [ Time Frame: one year ] [ Designated as safety issue: No ]We will measure functional connectivity using an rfcMRI sequence. Functional connectivity is sensitive to developmental delay.
- Intracranial Pressure (ICP) [ Time Frame: 1/1/2015 ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Experimental: craniofacial abnormalities
Subjects with craniosynostosis or other craniofacial abnormalities associated with ICP who will undergo an MR scan.
|Other: MR scan|
Active Comparator: normal control
normal control subjects who will undergo an MR scan
|Other: MR scan|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01898650
|Contact: Kamlesh Patel, MD||314 email@example.com|
|Contact: Gary Skolnick, BA||314 firstname.lastname@example.org|
|United States, Missouri|
|St. Louis Children's Hospital||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Gary Skolnick, BA 314-454-4005 email@example.com|
|Principal Investigator: Kamlesh Patel, MD|
|Principal Investigator:||Kamlesh Patel, MD||Washington University School of Medicine|