An observational study in Traumatic Brain Injury and Concussion, Brain, sponsored by Blinktbi, Inc.. Completed at 5 sites in United States. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-19.
Sponsored by Blinktbi, Inc. · Observational
Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice.
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.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's enrollment of 477 is above the median of 149 across 166 observational studies indexed under Brain Concussion.
Browse Brain Concussion studies →This is the only study on the registry with Blinktbi, Inc. as lead sponsor.
Compared within Brain Concussion, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Injuries, Traumatic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Healthy volunteers with a minimum age of 14yo. Any sex, nationality, sport played, etc are accepted.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
Accuracy of Concussion Diagnosis
The results from the Blink machine should match the physicians diagnosis.
Time frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
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.
Time frame: 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.
Time frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
Plan to share: Yes — All patient data will be anonymized prior to dissemination. Contact the sponsor for further details.
Supporting information: Study protocol, Informed consent form
Time frame: Protocol and ICF are available any time.
Access criteria: Case by case basis.
Data sharing details ↗ · www.blinktbi.com
Ran from Jan 2016 to primary completion in Apr 2018, 27 months.
Of 94 observational studies under Brain Concussion, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 64. This study's 27 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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