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

Recruitingn/aAges 18 Years - 65 YearsAllUniversity of Calgary
NCT05588115 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Foothills Medical Centre
Calgary, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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