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

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.

Study Overview

• Status: Completed
• Conditions: Eye-tracking
• Intervention / Treatment: Device: EYE-SYNC eye-tracking device; Other: SCAT-3; Device: Desktop Eye-Tracker

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  1. Clinical diagnosis of a psychotic disorder, bipolar disorder - lifetime
  2. Clinical diagnosis of ADHD or ADD - Lifetime
  3. Clinical diagnosis of major depressive disorder - within last year
  4. Clinical diagnosis of substance abuse disorder - within last year

  5. Clinical diagnosis of major anxiety disorder - within last year

     MEDICATION

  6. Requires use of a psychotropic medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Athletes; Participants will be evaluated using the EYE-SYNC eye-tracking device, Desktop Eye-Tracker, and Sport Concussion Assessment Tool (SCAT-3) tool.

Device: EYE-SYNC eye-tracking 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.; Other: SCAT-3; The Symptom subtest of SCAT-3 assessment tool will be administered to participants.; Device: Desktop Eye-Tracker; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error	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.	Up to 6 hours
Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error	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.	Up to 6 hours
Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain	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.	Up to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score	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.	Day of study/event (up to 6 hours)

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: United States Department of Defense; Department of Health and Human Services; Food and Drug Administration (FDA); U.S. Army Medical Research and Development Command; Brain Trauma Foundation
• Investigators: Principal Investigator: Jessica Little, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: April 29, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: concussion, eye-tracking, athletes, vision
• Other Study ID Numbers: 34662