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Completed

NCT Number: NCT02844543

EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 1

This study will assess the effects of exercise and non-concussive bodily contact on eye-tracking scores collected by the EYE-SYNC eye-tracking device.

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Key information

Conditions

Eye-tracking Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

The investigators propose to prospectively study a cohort of 18-25-year-old athletes. Athletes will be tested with the EYE-SYNC eye-tracking device prior to the start of an athletic practice or competition (pre-test) and then after the conclusion of the practice/competition (post-test). The investigators hope to understand if eye-tracking scores are effected by exercise and non-concussive bodily contact commonly incurred during athletic play.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Athletes between the age of 18- 25-years-old.
  • 20/30 or better eyesight (corrected vision allowed).
  • English fluency.

Exclusion criteria

Note: Under Cohort 1, Athletes that have conditions listed below will not be excluded from the study. They will be enrolled and their subject data will be analyzed separately from subjects who do not endorse any significant medical hx under neurological, eye-sight, or psychiatric categories.

  • Clinical diagnosis of a neurological condition including the following: Stroke, Multiple Sclerosis, Epilepsy, Brain Tumor/Cancer, Nystagmus and/or other major neurological condition.
  • Clinical diagnosis of any of the following eye-sight abnormalities: Uncorrected Amblyopia, Uncorrected Myopia, Uncorrected Presbyopia, Uncorrected Farsightedness, or Uncorrected Astigmatism.
  • Psychiatric history with any of the following:
  • Clinical diagnosis of a psychotic disorder, bipolar disorder - lifetime
  • Clinical diagnosis of ADHD or ADD - Lifetime
  • Clinical diagnosis of major depressive disorder - within last year
  • Clinical diagnosis of substance abuse disorder - within last year
  • Clinical diagnosis of major anxiety disorder - within last year

MEDICATION

  • Requires use of a psychotropic medication.

Treatment and study plan

EYE-SYNC eye-tracking device

Device

The EYE-SYNC® portable eye-tracking system. The eye tracker is a handheld isolated display environment with embedded eye tracking sensors. The eye tracker is connected to a high-performance Windows tablet though a customized docking station. Included accessories with EYE-SYNC are a U.S. tablet power supply adapter and disposable sanitary masks. Participants are asked to follow a dot with their eyes, as the dot moves on the screen of the EYE-SYNC device.

SCAT-3

Other

The Symptom subtest of SCAT-3 assessment tool will be administered to participants.

Desktop Eye-Tracker

Device

Eye movements are recorded with an eye tracking system (Desktop Eye-Tracker, Eyelink CR, SR Research) with up to 1000 Hz temporal resolution. The target stimulus is presented on a computer screen approximately 50 cm from the participant. Participants are asked to follow a dot with their eyes, as the dot moves on the monitor screen of the desk-top eye-tracking device.

Primary outcomes

  1. Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error

    Time frame: Up to 6 hours

    The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC.

    Phase error is defined as the difference in degrees between movement of the target and the movement of the eye. Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.

  2. Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error

    Time frame: Up to 6 hours

    The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC.

    Tangential and radial error are defined as degrees of variation in eye tracking along a circular path (tangential) and at 90 degrees to the tangential path (radial). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.

  3. Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain

    Time frame: Up to 6 hours

    The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC.

    Vertical and horizontal gain are defined as the ratio of velocity (velocity of the eye:velocity of the target). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.

Secondary outcomes

  1. Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score

    Time frame: Day of study/event (up to 6 hours)

    Change in SCAT-3 SAC score before and after practice or game is reported. The SAC score is based on the following assessments: number of symptoms (22 points), symptom severity (132 points), orientation (5 points), immediate memory (15 points), concentration (5 points), and delayed recall (5 points). Scores are summed for a possible range of 0 to 184, with lower scores corresponding to fewer concussion symptoms, and higher scores corresponding to more concussion symptoms.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Brain Trauma Foundation
  • Department of Health and Human Services
  • Food and Drug Administration (FDA)
  • U.S. Army Medical Research and Development Command
  • United States Department of Defense

Registry information

Acronym: ETA-TV

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 26, 2016
Registry last updated
May 30, 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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