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OpenTrials
Completed

NCT Number: NCT03381638

Understanding Concussion/Mild Traumatic Brain Injury

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

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Key information

Conditions

Traumatic Brain Injury Behavior Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Concussion, Brain Craniocerebral Trauma Fasting Feeding Behavior Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johnson. C. Smith University, Charlotte, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blink Reflexometer

Device

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.

Primary outcomes

  1. 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

  1. Contributing Factors

    Time frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.

    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.

  2. Average Baseline

    Time frame: Data unblinded May 1, 2018 or at completion of season, which ever comes first.

    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.

Sponsors and collaborators

Lead sponsor

Blinktbi, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2017
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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