Understanding Concussion/Mild Traumatic Brain Injury

Study Overview
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Brief Summary
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Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice.

Detailed Description
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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.

Official Title
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Understanding Concussion/Mild Traumatic Brain Injury

Conditions
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Traumatic Brain Injury, Concussion, Brain

Intervention / Treatment
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* Device: Blink Reflexometer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Volunteer<br>Volunteers who report to have never had a concussion and are not at high risk of getting a concussion are scanned to obtain a baseline of all ages, sex, race, etc. All patients will be scanned with the Blink Reflexometer. | Device: Blink Reflexometer<br>* 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.<br>|
| Concussion Protocol<br>Athletes who had a potential concussion and will go through any stage of the approved protocol, are scanned by the Blink Reflexometer device. Results are then analyzed prior to unblinding the clinical diagnosis from an Athletic Trainer and/or Neurologist. | Device: Blink Reflexometer<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Concussion Diagnosis | The results from the Blink machine should match the physicians diagnosis. | Data unblinded May 1, 2018 or at completion of season, which ever comes first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contributing Factors | 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. | Data unblinded May 1, 2018 or at completion of season, which ever comes first. | 
| Average Baseline | 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. | Data unblinded May 1, 2018 or at completion of season, which ever comes first. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Concussion, TBI, Sports, Medical Device, Fast