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

NCT05588115 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2026-02-05

No results posted yet for this study

Summary

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

  • Concussion, Mild

Sponsors & Collaborators

  • Foothills Medical Centre

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Chantel T Debert, MD, MSc · University of Calgary

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2025-04-30
Completion
2027-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05588115 on ClinicalTrials.gov