RecruitingNCT05588115

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

Sponsor

University of Calgary

Enrollment

225 participants

Start Date

Dec 1, 2022

Study Type

OBSERVATIONAL

Conditions

Concussion, Mild

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

diagnosed with an uncomplicated concussion according to the ICD-10 criteria with no intracranial abnormalities
between the ages of 18-65 years old.
diagnosed with any form of musculoskeletal injury in absence of comorbidities
between the ages of 18-65 years old

Exclusion Criteria4

complicated mild TBI (positive neuroimaging findings)
current or history of moderate or severe traumatic brain injury
history of neurological issue(s) (stroke, seizures, dementia, Alzheimer's, etc.) or metabolic disease(s) (diabetes, liver disease, kidney disease, cardiovascular disease, etc.)
greater than 7 days from injury at initial visit

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