Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT05588115

Conditions

Concussion, Mild

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

Brief 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

Study ID

NCT05588115

Start date

Dec 1, 2022

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Apr 30, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

225 participants

Anticipated

Interventions and Outcome Measures

Arms

Concussion

Patients presenting to the ED who are diagnosed with concussion according to the ICD-10 criteria and absent of comorbidities.

MSK

Patients presenting to the ED who are diagnosed with a muscle or skeletal injury (MSK; soft tissue damage or inflammation, fractured bone, etc.) and absent of comorbidities.

Primary outcome measure

  • Blood serum concentrations of GFAP at initial visit [ Time Frame: Up to 1 week following injury ]
  • Blood serum concentrations of GFAP at 2 week follow up [ Time Frame: 2-3 weeks following injury ]
  • Blood serum concentrations of GFAP at 6 week follow up [ Time Frame: 6-7 weeks following injury ]
  • Blood serum concentrations of GFAP at 12 week follow up [ Time Frame: 12-13 weeks following injury ]
  • Blood plasma concentrations of GFAP at initial visit [ Time Frame: Up to 1 week following injury ]
  • Blood plasma concentrations of GFAP at 2 week follow up [ Time Frame: 2-3 weeks following injury ]
  • Blood plasma concentrations of GFAP at 6 week follow up [ Time Frame: 6-7 weeks following injury ]
  • Blood plasma concentrations of GFAP at 12 week follow up [ Time Frame: 12-13 weeks following injury ]

Central Contacts and Locations

Central contacts

Chantel T Debert, MD, MSc

4039444500cdebert@ucalgary.ca

Linden C Penner, MSc

7802631373linden.penner@ucalgary.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Bianca M Perry, MSc

4039448643bianca.perry@ucalgary.ca

Christina Campbell, MSc

(403)944-8643Christina.Campbell@albertahealthservices.ca

Principal Investigator:

Chantel T Debert, MD, MSc

More Information

Sponsor

University of Calgary

Last update posted

Feb 5, 2026

Last verified

Jan, 2026

Keywords

  • blood biomarkers
  • GFAP
  • biosensor
  • concussion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-02-05.