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A Blood Test for Mild Traumatic Brain Injury and Concussion in Children and Youth - Changing the Management Paradigm

Award Number: R56NS057676
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ABSTRACT These are exciting times as a blood test for traumatic brain injury (TBI) is on the horizon. This R01 competitive renewal is a large-scale validation study that will extend the work that was successfully completed on serum TBI biomarkers in adults to children and youth, a previously understudied group. This multicenter study will systematically validate the diagnostic and prognostic ability of well-studied brain-specific protein and novel microRNA blood-based biomarkers in children and youth with mild traumatic brain injury (MTBI) and concussion using methods that have been systematically used in the adult studies. The protein biomarkers proposed here have been studied in adults and were shown to provide strong correlation to level of injury. This study will expand the focus to include promising microRNA biomarkers that have shown great promise in recently published pilot work. Young trauma patients will be enrolled from the emergency departments of adult and pediatric Level 1 Trauma Centers and will have blood drawn as soon after injury as possible. The first aim of this study will be to determine the brain-specificity of candidate biomarkers in children and youth with MTBI within four hours of injury. These markers' levels will be measured to see if they are present in those with other types of traumatic injuries and in those who hit their head but have no symptoms. The study will also assess concussion symptom severity. Being able to objectively distinguish someone with and without a concussion would be especially helpful in children who are too young to talk, in those who are confused after their injury, or in those with conditions that limit their ability to communicate (such as autism). The second aim will be to determine the diagnostic performance of the candidate biomarkers in young patients to detect critical injuries such as intracranial injuries on CT scan and those requiring urgent neurosurgery. The goal is help physicians make decisions on whether a CT scan is warranted. This will potentially decrease the number of CT scans performed, thereby reducing children's exposure to ionizing radiation. The third aim will be to assess the subacute and chronic diagnostic and prognostic utility of serially measured biomarkers over six months post- injury to determine neuropsychological function. The protocol calls for taking blood samples over 6 months to assess the ability of the biomarkers to predict whether children and youth will have neuropsychological problems. It will also assist in understanding the pattern of biomarker release during recovery. The ultimate goal of this research is to improve the clinical care of children and youth with MTBI and concussion by early recognition of injury and clinically validating a panel of blood-based markers that could be used by clinicians in the acute, subacute, and chronic phases of injury to determine the need for diagnostic imaging (CT or MRI), neurosurgery, specialized rehabilitation or risk for neuropsychological problems. Hopefully the results of this proposal will change clinical practice by providing medical professionals with more sensitive and accessible tools to detect brain injury and help patients and their families better understand their injury and recovery.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2018 ( Subtotal = -$589,682 )
2018	2017	ORLANDO HEALTH, INC.	52 WEST UNDERWOOD	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	4/10/2018	COMPETING CONTINUATION	-$589,682
														Subtotal = -$589,682

Issue Date FY: 2017 ( Subtotal = $589,682 )
2017	2017	ORLANDO HEALTH, INC.	52 WEST UNDERWOOD	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	9/22/2017	COMPETING CONTINUATION	$589,682
														Subtotal = $589,682

Grand Total All Awards = $0

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A Blood Test for Mild Traumatic Brain Injury and Concussion in Children and Youth - Changing the Management Paradigm

Award Number: R56NS057676

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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