New handheld device could spot concussions in minutes
NCT ID NCT05588115
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a small, handheld biosensor can accurately measure a brain injury protein (GFAP) in the blood of people with mild concussions. Researchers will compare the sensor's results to standard lab tests and track symptoms over 12 weeks. If it works, this device could allow for rapid, low-cost concussion diagnosis in emergency rooms or even at home.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- handheld biosensor for GFAP measurement
- What this could lead to
- If successful, this could lead to a simple, rapid test for concussion that patients can use at home, reducing the need for hospital visits.
- What could go wrong
- This is an early observational study, so the biosensor may not match lab accuracy. It also only includes mild concussions, so results may not apply to severe cases.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 225 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Foothills Medical Centre
RECRUITINGCalgary, Alberta, T2N 2T9, Canada
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Other studies related to the condition(s) this trial covers.
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- Can smarter discharge instructions help concussion patients heal faster?
- Could a Neck-Strengthening device speed up concussion recovery?
- Ice for the brain? new study tests cooling therapy for teen concussions
- Can a common supplement heal concussions faster?
- Smartphone check-ins could speed concussion recovery for teens