HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma II

Conditions
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Mild Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Cognitive Assessment
* Behavioral: Patient Reported Neurological Outcome Assessments
* Procedure: Blood Draw


Participation Criteria
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Eligibility Criteria
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Target Condition Subjects Inclusion Criteria: Age >=18 years Ability to provide a blood sample; within 96 hours of injury Ability to provide informed consent. Consent may be obtained with assistance of a legally authorized representative (LAR) Must present to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma Exclusion Criteria: Glasgow Coma Scale (GCS) score < 13, as presented in ED at time of screening Need for general anesthesia at the time of presentation in the ED Diagnosed dementia requiring assistance for daily living Any head trauma requiring medical attention from a physician within the last 6 months Received chemotherapy or radiation within the last year History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial surgery/hemorrhage Psychiatric hospitalization in the last 90 days Blood transfusion within the prior 4 weeks Non-working telephone number Current participant in an interventional clinical trial Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to read, inability to use both hands) Subject considered unsuitable for participation in this clinical trial by PI, treating clinician or research study staff Control Subjects Inclusion: Age >=18 years Ability to provide a blood sample; (For Trauma Controls (TC's) within 96 hours of injury) Ability to provide informed consent. (For TC's consent may be obtained with assistance of a legally authorized representative (LAR) Presents to the Emergency Department or Urgent Care with at least one injury requiring an X-Ray (TC's only) Healthy and not taking prescription medications (Healthy Controls (HC's) only) Exclusion: Head trauma or symptoms with head trauma at presentation Head trauma requiring medical attention from a physician within the last 6 months Internal organ injury (e.g. liver laceration, pulmonary contusion, spinal cord injury) that requires inpatient hospitalization Need for general anesthesia at the time of presentation in the ED Diagnosed dementia requiring assistance for daily living Received chemotherapy or radiation within the last year History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial surgery/hemorrhage Psychiatric hospitalization in the last 90 days Blood transfusion within the prior 4 weeks Non-working telephone number Current participant in an interventional clinical trial Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to read, inability to use both hands) Subject considered unsuitable for participation in this clinical trial by PI, treating clinician or research study staff

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Target Condition<br>Subjects presenting to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma | Behavioral: Cognitive Assessment<br>* Self administered cognitive battery<br>Behavioral: Patient Reported Neurological Outcome Assessments<br>* Standard neurocognitive and neuropsychological tests<br>Procedure: Blood Draw<br>* Specimen collection of whole blood, serum, RNA<br>|
| Trauma Control<br>Subjects presenting to the ED or UC requiring an Xray but do not have a head trauma | Behavioral: Cognitive Assessment<br>* Self administered cognitive battery<br>Behavioral: Patient Reported Neurological Outcome Assessments<br>* Standard neurocognitive and neuropsychological tests<br>Procedure: Blood Draw<br>* Specimen collection of whole blood, serum, RNA<br>|
| Healthy Control<br>Subjects that are healthy and not taking any prescription medications | Behavioral: Cognitive Assessment<br>* Self administered cognitive battery<br>Procedure: Blood Draw<br>* Specimen collection of whole blood, serum, RNA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation 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 | 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 | up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, mTBI