Actively Recruiting

Age: 18Years - 65Years
All Genders
ID05588115

Rapid, Accurate and Cost-effective Analysis of Glial Fibrillary Acid Protein Using a Hand-held Biosensor for Patients With Concussion in Acute Care and Home Monitoring

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

225

Participants Needed

1

Research Sites

135 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

Researchers are evaluating a hand-held biosensor designed to measure a blood biomarker called glial fibrillary acidic protein (GFAP) in adults with concussion. The study aims to determine if this biosensor can measure GFAP as accurately as the current standard technique and explore whether these measurements relate to psychological and physical symptoms of concussion. The study will compare concussion patients to those with musculoskeletal injuries to see if the biosensor's readings are specific to concussion. The study involves recruiting adults aged 18 to 65 who come to the emergency department with either concussion or musculoskeletal injuries. Concussion participants will have blood samples taken and complete questionnaires at their initial visit within 1 week of injury, then again at 2, 6, and 12 weeks after injury. Those not recovered by 12 weeks will also be followed up at 6 months. Musculoskeletal injury participants will complete measures at a single visit. The biosensor readings will be compared with the standard assay technique called SIMOA. Participants provide blood samples and complete various assessments including quality of life, mental health, sleep, and concussion symptoms. Concussion patients will report daily symptoms through an online scale to monitor recovery. Researchers will analyze blood biomarker levels in serum and plasma over time, and assess how these relate to recovery and symptoms. The study includes a follow-up period up to 6 months for some participants to better understand the biosensor's clinical performance and recovery patterns.

CONDITIONS

Brief 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 with no brain abnormalities
  • Aged between 18 and 65 years for concussion group
  • Diagnosed with musculoskeletal injury without other health conditions
  • Aged between 18 and 65 years for musculoskeletal injury 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, Alzheimer's disease
  • History of metabolic diseases including diabetes, liver disease, kidney disease, cardiovascular disease
  • More than 7 days have passed since injury at the initial visit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 1 week

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) within 1 week of injury

Diagnostic Evaluation

Duration - Up to 1 week

Participants diagnosed with concussion or musculoskeletal injury complete baseline assessments and blood draws to measure GFAP biomarker levels and symptom questionnaires.

1 visit (in-person) within 1 week of injury

Long-term Monitoring

Duration - 12 weeks or until recovery, with additional follow-up at 6 months if not recovered

Concussion participants complete follow-up visits to monitor recovery through biomarker measurements, clinical assessments, and questionnaires. Daily symptom tracking is done via an online scale.

Follow-up visits at 2, 6, and 12 weeks post-injury; daily online symptom reporting; possible questionnaire at 6 months

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

L

Linden C Penner, MSc

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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Published Research Related To This Trial

Incidence, risk factors and prevention of mild traumatic brain injury: results of the WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury.

J David Cassidy, Linda J Carroll, Paul M Peloso...

https://pubmed.ncbi.nlm.nih.gov/15083870

Consensus statement on concussion in sport-the 5th international conference on concussion in sport held in Berlin, October 2016.

Paul McCrory, Willem Meeuwisse, Jiří Dvořák...

https://pubmed.ncbi.nlm.nih.gov/28446457

Role of advanced neuroimaging, fluid biomarkers and genetic testing in the assessment of sport-related concussion: a systematic review.

Michael McCrea, Timothy Meier, Daniel Huber...

https://pubmed.ncbi.nlm.nih.gov/28455364