Concussion, Brain, Traumatic Brain Injury
Conditions
Keywords
Concussion, TBI, Sports, Medical Device, Fast
Brief summary
Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice.
Detailed description
In a blinded trial, any patient who during a game or practice situation had head contact, thus possible Traumatic Brain Injury (TBI) aka Concussion, in addition to the current approved protocols, patients are scanned with the Blink Reflexometer. Results are not available until the end of the season, thus eliminating the potential of someone relying on the results. The Blink Reflexometer uses 5 puffs of air on the side of the eye over 20 seconds. The air causes a blink reflex which is being correlated to a concussion. The results of the blink post concussion are compared to a baseline scan taken at the beginning of the season.
Interventions
DEVICEBlink Reflexometer
The device uses 5 light puffs of air to the side of the eye causing a blink reflex that is captured by the high-speed camera tracking the eyelids.
Sponsors
Blinktbi, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Read, understand and sign patient consent (parent approval needed when pt is under 18yo)
Exclusion criteria
* Diagnosed concussion in past 4 weeks * Ingesting any drugs banned by the US Anti-doping Association (USADA) * Never prior diagnosed with a neurological abnormality, including Alzheimer's, MS, Huntington's, Epilepsy, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Concussion Diagnosis | Data unblinded May 1, 2018 or at completion of season, which ever comes first. | The results from the Blink machine should match the physicians diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contributing Factors | Data unblinded May 1, 2018 or at completion of season, which ever comes first. | There are a number of factors that could possible change the blink reflex such as Caffeine and Tobacco. We are capturing this data to confirm that the device can be accurate despite a patient ingesting these items. |
| Average Baseline | Data unblinded May 1, 2018 or at completion of season, which ever comes first. | The goal is to eliminate the need for requiring a baseline scan on a patient in order to decide if they have a concussion or not. By scanning a large number of normal volunteers at various ages, sex, race, etc, we expect to see trends based on these factors. |
Countries
United States
Outcome results
None listed