MRI Markers of Outcome After Severe Pediatric TBI
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|ClinicalTrials.gov Identifier: NCT02688660|
Recruitment Status : Suspended (Due to COVID-19)
First Posted : February 23, 2016
Last Update Posted : July 26, 2021
|Condition or disease||Intervention/treatment|
|Brain Injuries||Other: MRI Scans|
Severe pediatric TBI results in a range of neurocognitive and behavioral deficits with resultant impact on school performance, social functioning, and quality of life. Sixty percent of children suffer from long-term functional impairments after severe TBI, and more than 40% demonstrate deficits in multiple cognitive and psychological domains. Importantly, a recent meta-analysis revealed that rather than catching up to their peers in these domains, children with severe TBI fall further behind over time. These deficits in cognitive and emotional function have a major impact on the child's quality of life after a TBI. A large study recently reported that severe TBI patients demonstrated lower quality of life than children undergoing active treatment for cancer. Considerable variation exists in the severity of impairment within each cognitive domain from patient to patient, likely relating to the mechanism of injury, the type and location of lesion, patient age, and pre-morbid functioning among other factors. While clinical scales such as the Glasgow Coma Scale (GCS) are useful for assessing injury severity and may provide general prognostic information, they are insufficient to identify risk for specific cognitive deficits. Identifying predictors of impairment within specific domains would aid in directing rehabilitation strategies towards at-risk cognitive domains, thereby improving long-term function and quality of life.
The investigators are partnering with an ongoing pediatric TBI trial (ADAPT Trial: Approaches and Decisions in Acute Pediatric TBI) and will also be enrolling past UW patients and healthy controls. Consistency in timing of follow-up scans, large sample size and access to the ADAPT Trial injury severity data and neuropsychological testing will give this study unprecedented power to assess the relationship between early MRI findings and subsequent atrophy, white matter injury, network connectivity changes and neurocognitive and behavioral impairments.
|Study Type :||Observational|
|Estimated Enrollment :||950 participants|
|Official Title:||MRI Markers of Outcome After Severe Pediatric Traumatic Brain Injury (TBI)|
|Actual Study Start Date :||April 1, 2016|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
ADAPT Study Population
This cohort will be subjects from the ADAPT study who had an acute MRI scan which has been uploaded into the ADAPT database from all participating sites.
This cohort will include patients from ADAPT sites who choose to participate in this option and obtain a follow-up MRI approximately 1 year after the TBI.
Other: MRI Scans
This cohort will have one MRI to be used in comparison of the above cohorts.
Other: MRI Scans
- Cerebral Atrophy [ Time Frame: 1 year ]Global and regional cerebral atrophy will be assessed using MRI
- White matter fractional anisotropy [ Time Frame: 1 year ]Fractional Anisotropy will be assessed using Diffusion Tensor MRI
- Brain network connectivity [ Time Frame: 1 year ]Network connectivity will be assessed using resting-state functional MRI
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): NCT02688660
|Principal Investigator:||Peter Ferrazzano, MD||University of Wisconsin, Madison|