The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in the diagnosis and prognosis of patients with mild traumatic brain injury, by incorporating blood biomarkers, clinical assessments, and tools to measure associated neurocognitive impairments.
This study proposes to collect data using a multi-modality approach including blood biomarkers, clinical assessments, neurocognitive performance, and neuropsychological characteristics, to identify subjects with a mild Traumatic Brain Injury (TBI) and their likelihood of chronic symptoms. This is an observational study with an expectation of enrolling up to 2000 subjects. These subjects will include the intended use population, subjects presenting to the Emergency Department or Urgent Care with a blunt head trauma. Data will be collected across four time points, T=0, 14 days, 30 days and 90 days, to allow for building and validating the algorithms for both diagnosis and prognosis claims. Control populations, healthy and trauma only (no head trauma) will be included for assay development. Data will be collected for these groups at T=0 and 14 days (trauma control only).
Study Type
OBSERVATIONAL
Enrollment
2,000
Self administered cognitive battery
Standard neurocognitive and neuropsychological tests
Specimen collection of whole blood, serum, RNA
University of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGDetroit Receiving
Detroit, Michigan, United States
RECRUITINGCorrelation of mild traumatic brain injury diagnosis using the BRAINBox TBI Test compared to the Expert Clinical Diagnosis
Sensitivity and specificity of the diagnosis as compared to a clinical diagnosis by an expert committee
Time frame: 30 days
Determine the risk stratification of having symptoms at 14, 30 and 90 days, for subjects with mild traumatic brain injury using the BRAINBox TBI Test results.
Sensitivity and specificity of the risk for chronic symptoms as compared to the post-concussion symptoms at predefined time points
Time frame: up to 90 days
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Harper University Hospital
Detroit, Michigan, United States
RECRUITINGSinai Grace Hospital
Detroit, Michigan, United States
RECRUITINGUniversity of Rochester Medical Center
Rochester, New York, United States
RECRUITINGStony Brook Medicine
Stony Brook, New York, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGJohn Peter Smith (JPS) Health Network
Fort Worth, Texas, United States
RECRUITINGBaylor College of Medicine/Ben Taub
Houston, Texas, United States
RECRUITINGBaylor College of Medicine/St. Luke's Medical Center
Houston, Texas, United States
RECRUITING...and 1 more locations