Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT05588115

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

Led by University of Calgary · Updated on 2026-02-05

225

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

U

University of Calgary

Lead Sponsor

F

Foothills Medical Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with an uncomplicated concussion according to ICD-10 criteria without intracranial abnormalities
  • Aged between 18 and 65 years
  • Diagnosed with any form of musculoskeletal injury without comorbidities (for MSK group)
  • Aged between 18 and 65 years (for MSK group)
Not Eligible

You will not qualify if you...

  • Complicated mild traumatic brain injury with positive neuroimaging findings
  • Current or history of moderate or severe traumatic brain injury
  • History of neurological issues such as stroke, seizures, dementia, or Alzheimer's disease
  • History of metabolic diseases including diabetes, liver, kidney, or cardiovascular disease
  • Initial visit more than 7 days after injury

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Foothills Medical Centre

Calgary, Alberta, Canada, T2N 2T9

Actively Recruiting

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Research Team

C

Chantel T Debert, MD, MSc

CONTACT

L

Linden C Penner, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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