NCT05588115 Rapid, Accurate, Cost-effective Assessment of Blood Biomarkers for Diagnosis of Concussion
| NCT ID | NCT05588115 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Concussion, Mild |
| Study Type | OBSERVATIONAL |
| Enrollment | 225 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 225 participants in total. It began in 2022-12-01 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Chantel T Debert, MD, MSc
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT05588115 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Concussion, Mild. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05588115 currently recruiting?
Yes, NCT05588115 is actively recruiting participants. Contact the research team at cdebert@ucalgary.ca for enrollment information.
Where is the NCT05588115 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT05588115 clinical trial?
NCT05588115 is sponsored by University of Calgary. The principal investigator is Chantel T Debert, MD, MSc at University of Calgary. The trial plans to enroll 225 participants.