NCT03381638

Understanding Concussion/Mild Traumatic Brain Injury

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 477 (actual)
• Sponsor: Blinktbi, Inc. · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Traumatic Brain Injury
• Concussion, Brain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-04-17
• Completion: 2018-04-17
• First posted: 2017-12-22
• Last updated: 2018-04-19

Locations

5 sites across 1 country: United States