RECRUITINGOBSERVATIONAL

Rapid, Accurate, Cost-effective Assessment of Blood Biomarkers for Diagnosis of Concussion

RACE Study: Rapid, Accurate and Cost-effective Analysis of Glial Fibrillary Acid Protein Using a Hand-held Biosensor for Patient With Concussion in Acute Care and at Home Monitoring

About This Trial

The goal of this observational study is to test if a biosensor can accurately measure a blood biomarker in adult patients presenting to the emergency department with concussion. The main questions it aims to answer are: * Does the biosensor measure the blood biomarker of interest with the same accuracy as the current gold-standard assay technique? * Do relationships exist between blood biomarker measurements from the biosensor and any psychological or physical symptoms of concussion? Participants will be asked to provide blood samples at initial visit and 2-, 6-, and 12-weeks after injury while completing questionnaires at each visit, along with a brief (2 min) daily symptom inventory. Researchers will compare the concussion group to a muscle/skeletal injury group to see if measurements from the biosensor are exclusive to concussion.

Who May Be Eligible (Plain English)

Inclusion Criteria (concussion group): 1. diagnosed with an uncomplicated concussion according to the ICD-10 criteria with no intracranial abnormalities 2. between the ages of 18-65 years old. Inclusion Criteria (MSK group): 1. diagnosed with any form of musculoskeletal injury in absence of comorbidities 2. between the ages of 18-65 years old Who Should NOT Join This Trial: 1. complicated mild TBI (positive neuroimaging findings) 2. current or history of moderate or severe traumatic brain injury 3. history of neurological issue(s) (stroke, seizures, dementia, Alzheimer's, etc.) or metabolic disease(s) (diabetes, liver disease, kidney disease, cardiovascular disease, etc.) 4. greater than 7 days from injury at initial visit Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria (concussion group): 1. diagnosed with an uncomplicated concussion according to the ICD-10 criteria with no intracranial abnormalities 2. between the ages of 18-65 years old. Inclusion Criteria (MSK group): 1. diagnosed with any form of musculoskeletal injury in absence of comorbidities 2. between the ages of 18-65 years old Exclusion Criteria: 1. complicated mild TBI (positive neuroimaging findings) 2. current or history of moderate or severe traumatic brain injury 3. history of neurological issue(s) (stroke, seizures, dementia, Alzheimer's, etc.) or metabolic disease(s) (diabetes, liver disease, kidney disease, cardiovascular disease, etc.) 4. greater than 7 days from injury at initial visit

Locations (1)

Foothills Medical Centre

Calgary, Alberta, Canada