Understanding Concussion/Mild Traumatic Brain Injury

Blinktbi, Inc.477 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

477

Conditions

Traumatic Brain Injury Concussion, Brain

Interventions

Blink ReflexometerDEVICE

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.

Eligibility

Sex: ALLMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

Johnson. C. Smith University

Charlotte, North Carolina, United States

Hershey Bears Ice Hockey Team

Hershey, Pennsylvania, United States

The Citadel

Charleston, South Carolina, United States

South Carolina Stingrays

North Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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