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

Recruiting now

Conditions studied: Concussion, Mild

In brief

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.

Key facts

Study ID

NCT05588115

Run by

University of Calgary

People needed

225

Starts

2022-12-01

Expected to finish

2027-12-01

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Foothills Medical Centre — Calgary, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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