Rapid, accurate, low-cost blood test to help diagnose concussion
RACE Study: Rapid, Accurate and Cost-effective Analysis of Glial Fibrillary Acid Protein Using a Hand-held Biosensor for Patient With Concussion in Acute Care and at Home Monitoring
This study will test if a portable biosensor can accurately measure a blood biomarker (GFAP) to help diagnose concussion in adults who come to the emergency department.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05588115 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults 18–65 with a recent (within 7 days) uncomplicated concussion presenting to the emergency department, or adults 18–65 with a musculoskeletal injury for the comparison group.
Not a fit: People with complicated mild TBI (positive neuroimaging), a history of moderate/severe TBI, preexisting neurological or major metabolic disease, or those more than 7 days from injury are not likely to benefit from this study.
Why it matters
Potential benefit: If successful, the biosensor could enable faster, cheaper bedside blood testing to support concussion diagnosis and track recovery.
How similar studies have performed: Prior research supports GFAP as a useful blood biomarker for brain injury, but using a portable biosensor for rapid, low-cost measurement is an emerging approach that is only partially validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Calgary, Alberta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.