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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Blood serum concentrations of GFAP at initial visit — Up to 1 week following injury Compare serum concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.
Blood serum concentrations of GFAP at 2 week follow up — 2-3 weeks following injury Compare serum concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.
Blood serum concentrations of GFAP at 6 week follow up — 6-7 weeks following injury Compare serum concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.
Blood serum concentrations of GFAP at 12 week follow up — 12-13 weeks following injury Compare serum concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.
Blood plasma concentrations of GFAP at initial visit — Up to 1 week following injury Compare plasma concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.
Blood plasma concentrations of GFAP at 2 week follow up — 2-3 weeks following injury Compare plasma concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.
Blood plasma concentrations of GFAP at 6 week follow up — 6-7 weeks following injury Compare plasma concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.
Blood plasma concentrations of GFAP at 12 week follow up — 12-13 weeks following injury Compare plasma concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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