Understanding Concussion/Mild Traumatic Brain Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Blinktbi, Inc.
- Enrollment
- 477
- Locations
- 5
- Primary Endpoint
- Accuracy of Concussion Diagnosis
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Accuracy of Concussion Diagnosis
Time Frame: 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 Outcomes
- Contributing Factors(Data unblinded May 1, 2018 or at completion of season, which ever comes first.)
- Average Baseline(Data unblinded May 1, 2018 or at completion of season, which ever comes first.)