Wednesday, March 12, 2025 3/12/2025

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

Award Number: R01NS057676
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 PROJECT SUMMARY These are exciting times as a blood test for traumatic brain injury is on the horizon. This R01 competitive renewal is a large scale validation study that will extend the work we have done on serum biomarkers in adults to children and youth, previously understudied groups. This proposal will systematically validate the diagnostic and prognostic ability of well-studied serum protein biomarkers and promising microRNA serum biomarkers in children and youth with mild traumatic brain injury (MTBI) and concussion. The biomarkers being proposed here have been studied in adults in data published by our group. Moreover, we will be examining promising microRNA biomarkers that we have evaluated in recently published pilot work. Patients will be enrolled from the emergency departments of adult and pediatric Level 1 Trauma Centers. Our first aim is will assess the brain-specificity of candidate biomarkers in determining presence of MTBI/concussion versus other traumatic injuries and head trauma without symptoms, as well as determining baseline levels by age and gender in uninjured children and youth. Being able to distinguish someone with and without a concussion would be so helpful, especially in children who cannot talk yet or with conditions such as autism spectrum disorders who cannot express themselves. Our second aim will assess the diagnostic performance of candidate biomarkers in detecting critical injuries such as intracranial lesions on CT scan and acute neurological complications and will compare biomarker performance to validated clinical decision rules. This could potentially help reduce the number of CT scans done on children and reduce their exposure to ionizing radiation. Our third and final aim will assess the prognostic utility of serially measured biomarkers over six months in determining impairment or problems functioning. It will also help us understand the pattern of biomarker release over time in children and youth as it relates to recovery from injury. The 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 (blood test) 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), acute neurological complications, specialized rehabilitation, or long-term risk for neurocognitive impairment. Ultimately, we hope the results of the proposal will change clinical practice by providing medical professional with more sensitive 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: 2024 ( Subtotal = $0 )
2024	2022	ORLANDO HEALTH, INC	1414 KUHL AVE # MP2	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	10	6/12/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	ORLANDO HEALTH, INC.	1414 KUHL AVENUE	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	10	7/24/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $705,132 )
2022	2022	ORLANDO HEALTH, INC.	1414 KUHL AVENUE	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	10	5/13/2022	NON-COMPETING CONTINUATION	$705,132
														Subtotal = $705,132

Issue Date FY: 2021 ( Subtotal = $706,970 )
2021	2021	ORLANDO HEALTH, INC.	1414 KUHL AVENUE	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	9	7/5/2021	NON-COMPETING CONTINUATION	$706,970
														Subtotal = $706,970

Issue Date FY: 2020 ( Subtotal = $709,836 )
2020	2020	ORLANDO HEALTH, INC.	1414 KUHL AVENUE	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	8	6/9/2020	NON-COMPETING CONTINUATION	$709,836
														Subtotal = $709,836

Issue Date FY: 2019 ( Subtotal = $714,113 )
2019	2019	ORLANDO HEALTH, INC.	52 W UNDERWOOD ST	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	5/16/2019	NON-COMPETING CONTINUATION	$714,113
														Subtotal = $714,113

Issue Date FY: 2018 ( Subtotal = $766,000 )
2018	2018	ORLANDO HEALTH, INC.	52 W UNDERWOOD ST	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	7/5/2018	COMPETING CONTINUATION	$766,000
														Subtotal = $766,000

Issue Date FY: 2015 ( Subtotal = $0 )
2015	2012	Orlando Health, Inc.	5655 S. Orange Ave.	ORLANDO	FL	32809	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	8/25/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $0 )
2014	2012	Orlando Health, Inc.	5655 S. Orange Ave.	ORLANDO	FL	32809	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	7/24/2014	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2012 ( Subtotal = $441,143 )
2012	2012	ORLANDO HEALTH, INC.	1414 KUHL AVE, MAIL POINT 47	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	6/27/2012	NON-COMPETING CONTINUATION	$441,143
														Subtotal = $441,143

Issue Date FY: 2011 ( Subtotal = $444,935 )
2011	2011	ORLANDO HEALTH, INC.	1414 KUHL AVE, MAIL POINT 47	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	7/11/2011	NON-COMPETING CONTINUATION	$444,935
														Subtotal = $444,935

Issue Date FY: 2010 ( Subtotal = $442,192 )
2010	2010	ORLANDO REGIONAL HEALTHCARE SYSTEM, INC	1414 KUHL AVE, MAIL POINT 47	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	7/13/2010	NON-COMPETING CONTINUATION	$442,192
														Subtotal = $442,192

Issue Date FY: 2009 ( Subtotal = $437,421 )
2009	2009	ORLANDO REGIONAL HEALTHCARE SYSTEM, INC	1414 KUHL AVE, MAIL POINT 47	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	8/5/2009	NON-COMPETING CONTINUATION	$437,421
														Subtotal = $437,421

Issue Date FY: 2008 ( Subtotal = $450,462 )
2008	2008	ORLANDO REGIONAL HEALTHCARE SYSTEM, INC	1414 KUHL AVE, MAIL POINT 47	ORLANDO	FL	32806	ORANGE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/23/2008	NEW	$450,462
														Subtotal = $450,462

Grand Total All Awards = $5,818,204

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

Award Number: R01NS057676

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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