Mild Traumatic Brain Injury
Conditions
Keywords
TBI, mTBI
Brief summary
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
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).
Interventions
BEHAVIORALCognitive Assessment
Self administered cognitive battery
BEHAVIORALPatient Reported Neurological Outcome Assessments
Standard neurocognitive and neuropsychological tests
PROCEDUREBlood Draw
Specimen collection of whole blood, serum, RNA
Sponsors
BRAINBox Solutions Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Target Condition Subjects Inclusion Criteria: 1. Age \>=18 years 2. Ability to provide a blood sample; within 96 hours of injury 3. Ability to provide informed consent. Consent may be obtained with assistance of a legally authorized representative (LAR) 4. Must present to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma
Exclusion criteria
1. Glasgow Coma Scale (GCS) score \< 13, as presented in ED at time of screening 2. Need for general anesthesia at the time of presentation in the ED 3. Diagnosed dementia requiring assistance for daily living 4. Any head trauma requiring medical attention from a physician within the last 6 months 5. Received chemotherapy or radiation within the last year 6. History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial surgery/hemorrhage 7. Psychiatric hospitalization in the last 90 days 8. Blood transfusion within the prior 4 weeks 9. Non-working telephone number 10. Current participant in an interventional clinical trial 11. Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to read, inability to use both hands) 12. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician or research study staff Control Subjects Inclusion: 1. Age \>=18 years 2. Ability to provide a blood sample; (For Trauma Controls (TC's) within 96 hours of injury) 3. Ability to provide informed consent. (For TC's consent may be obtained with assistance of a legally authorized representative (LAR) 4. Presents to the Emergency Department or Urgent Care with at least one injury requiring an X-Ray (TC's only) 5. Healthy and not taking prescription medications (Healthy Controls (HC's) only) Exclusion: 1. Head trauma or symptoms with head trauma at presentation 2. Head trauma requiring medical attention from a physician within the last 6 months 3. Internal organ injury (e.g. liver laceration, pulmonary contusion, spinal cord injury) that requires inpatient hospitalization 4. Need for general anesthesia at the time of presentation in the ED 5. Diagnosed dementia requiring assistance for daily living 6. Received chemotherapy or radiation within the last year 7. History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial surgery/hemorrhage 8. Psychiatric hospitalization in the last 90 days 9. Blood transfusion within the prior 4 weeks 10. Non-working telephone number 11. Current participant in an interventional clinical trial 12. Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to read, inability to use both hands) 13. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician or research study staff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of mild traumatic brain injury diagnosis using the BRAINBox TBI Test compared to the Expert Clinical Diagnosis | 30 days | Sensitivity and specificity of the diagnosis as compared to a clinical diagnosis by an expert committee |
| 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. | up to 90 days | Sensitivity and specificity of the risk for chronic symptoms as compared to the post-concussion symptoms at predefined time points |
Countries
United States
Contacts
Primary ContactDonna Edmonds
Backup ContactAndrea Brown, MS
Outcome results
None listed