Rapid, Accurate, Cost-effective Assessment of Blood Biomarkers for Diagnosis of Concussion
ConditionConcussion, Mild
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Calgary
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosed with an uncomplicated concussion according to the ICD-10 criteria with no intracranial abnormalities
between the ages of 18-65 years old.
diagnosed with any form of musculoskeletal injury in absence of comorbidities
between the ages of 18-65 years old
Disqualifiers
complicated mild TBI (positive neuroimaging findings)
current or history of moderate or severe traumatic brain injury
history of neurological issue(s) (stroke, seizures, dementia, Alzheimer's, etc.) or metabolic disease(s) (diabetes, liver disease, kidney disease, cardiovascular disease, etc.)
greater than 7 days from injury at initial visit
Trial population
For the exposure of interest group, adult patients (ages 18 to 65) with an uncomplicated concussion diagnosis at Foothills Medical Centre Emergency Department in Calgary Alberta will be approached to participate in this study regardless of race, ethnicity, or gender. For the control group, adult patients (ages 18 to 65) with a musculoskeletal (MSK) injury (fractured bone, connective tissue damage, etc.) at Foothills Medical Centre Emergency Department in Calgary Alberta will be approached to participate in this study regardless of race, ethnicity, or gender.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
225 Participants
are grouped into 2 trial groupsGroup A: Concussion
Group B: MSK
Trial outcomes
Primary outcomes
1
Blood serum concentrations of GFAP at initial visit
Compare serum concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.
Time frame
Up to 1 week following injury2
Blood serum concentrations of GFAP at 2 week follow up
Compare serum concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.
Time frame
2-3 weeks following injury3
Blood serum concentrations of GFAP at 6 week follow up
Compare serum concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.
Time frame
6-7 weeks following injury4
Blood serum concentrations of GFAP at 12 week follow up
Compare serum concentrations of GFAP measured by the biosensor and the current gold-standard SIMOA technology.
Time frame
12-13 weeks following injurySecondary outcomes
1
Glasgow Outcome Scale Extended (GOSE)
Assesses outcomes following brain injury. Scores range from 1 to 8 with higher scores meaning better outcomes.
Time frame
Up to 1 week following injury2
Glasgow Outcome Scale Extended (GOSE)
Assesses outcomes following brain injury. Scores range from 1 to 8 with higher scores meaning better outcomes.
Time frame
2-3 weeks following injury3
Glasgow Outcome Scale Extended (GOSE)
Assesses outcomes following brain injury. Scores range from 1 to 8 with higher scores meaning better outcomes.
Time frame
6-7 weeks following injury4
Glasgow Outcome Scale Extended (GOSE)
Assesses outcomes following brain injury. Scores range from 1 to 8 with higher scores meaning better outcomes.
Time frame
12-13 weeks following injurySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Calgary
Lead sponsor
Foothills Medical Centre
Collaborator
Source ClinicalTrials.gov