Rapid, accurate, low-cost blood test to help diagnose concussion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll adults (18–65) with uncomplicated concussion and a comparison group with musculoskeletal injury, collecting blood at the initial visit and at 2, 6, and 12 weeks plus brief questionnaires and daily symptom check-ins. Researchers will compare biomarker levels measured by the biosensor to the current laboratory gold-standard assay to determine agreement and accuracy. They will also analyze whether biosensor measurements relate to patients' physical and psychological symptoms over time. The concussion group will be compared to the musculoskeletal group to test whether biosensor signals are specific to brain injury.

Why it matters

Who can join: the full rules

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

Where it's running

• Foothills Medical Centre
  Calgary, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Chantel T Debert, MD, MSc — University of Calgary
• Study coordinator: Chantel T Debert, MD, MSc
• Email: cdebert@ucalgary.ca
• Phone: 4039444500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.