EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 2 (ETA-TV)

This is a prospective multi-center cohort feasibility and exploratory study.

Study Overview

• Status: Terminated
• Conditions: Eye-tracking
• Intervention / Treatment: Device: EYE-SYNC eye-tracking; Other: SCAT-3 subtests; Other: DEM; Other: Simple Reaction Time subtest of ANAM-SRT; Other: Level of Alertnesss

Detailed Description

Investigators propose to prospectively study a cohort of 18-25-year-old athletes to establish the reliability of EYE-SYNC data and the utility of the EYE-SYNC eye-tracking device as a sideline concussion assessment tool. The clinical research study will be conducted to 1) determine if eye-tracking, assessed on the sideline by EYE-SYNC eye-tracking device, is a potential marker of injury that can be used in conjunction with other sideline evaluations to inform decisions regarding removal of athletes from play and 2) to use the EYE-SYNC goggle data as a post- injury recovery monitor.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • University of Southern California
    • Santa Barbara, California, United States, 93106
      • University of California Santa Barbara
  • Oregon
    • Corvallis, Oregon, United States, 97331
      • Oregon State University
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 21 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Both CCS and CTR must meet the following 3 criteria:

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

Control Subject:

• Control Subject (CTR) - a teammate of the concussed subject who did not experience impact but who was actively participating in the same sport and session along with the injured teammate at the time of injury

Concussed Subject:

Concussed Subject (CCS) - those who experience impact where concussion is highly suspected as evidenced by impairment in any of the SCAT-3 Domains: Symptoms, Physical Signs, Immediate Memory and Orientation. An Injured Athlete is concussed if he/she is FAIL on the Physical Signs, Score = 0 on the Orientation or Scoring below the cutoff scores on the Symptom Checklist and/or Immediate memory SCAT-3 domains.

A) Symptoms: Rating of 2 or higher on any of the following items:

1. Headaches
2. Nausea or Vomiting
3. Dizziness
4. Balance Problems
5. Blurred Vision
6. Feeling Slowed Down
7. Feeling like "in a fog"
8. "Don't feel right"

B) Physical Signs:

Balance (Leg Stances): Number of Error(s) on any of the following 7 subtests classifies a subject as concussed.

I. Double Leg Stance: At least 3 errors II. Single Leg Stance: At least 3 errors with either dominant or non-dominant foot III. Tandem Stance: At least 3 errors or more.

Balance (Tandem Gait): FAIL on at least 2 of 4 trials:

I. FAIL per trial: more than 14 seconds to complete a trial II. FAIL per trial, if one or more of the following errors are made

1. If step off the line;
2. Separation between heel and toe
3. Touch/grab the examiner or an object

D) Orientation: Score = 0 on any of the following 5 items Date: Score = 0 (any date different from current) Month: Score = 0 (any month different from current) Day of the week: Score = 0 (any different from current) Year: Score = 0 (any different from current) Time: Score = 0 AND answer is MORE than + or - 1 hour apart from the correct time.

E) Immediate Memory Recall Total Score = less than 13 words recalled.

Exclusion Criteria:

• 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.
• Cannot have participated previously in any of the ETA-TV study visits (for instance, a subject that has completed any study visit as a control subject cannot participate as a concussed subject at a later time point).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concussed Subject; EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM. Investigators will be collecting medical history and demographics from each subject.	Device: EYE-SYNC eye-tracking; 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 subtests; Following subtests of SCAT-3 will be administered to the participant: Symptom, Balance, Orientation and Immediate memory; Other Names: Sport Concussion Assessment Tool; Other: DEM; Participant will be asked to read list of numbers out loud from a card; Other Names: Developmental Eye Movement; Other: Simple Reaction Time subtest of ANAM-SRT; Participants will perform Simple Reaction Time sub-test of ANAM-SRT test. They will be asked to click the mouse button every time they see an asterisk on the screen. Participants will perform ANAM-SRT 1 and ANAM-SRT 2 in this study.; Other Names: Automated Neuropsychological Assessment Metrics; Other: Level of Alertnesss; Participants will answer questions. This assessment is to assess their alertness level.
Active Comparator: Control Subject; EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM. Investigators will be collecting medical history and demographics from each subject.	Device: EYE-SYNC eye-tracking; 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 subtests; Following subtests of SCAT-3 will be administered to the participant: Symptom, Balance, Orientation and Immediate memory; Other Names: Sport Concussion Assessment Tool; Other: DEM; Participant will be asked to read list of numbers out loud from a card; Other Names: Developmental Eye Movement; Other: Simple Reaction Time subtest of ANAM-SRT; Participants will perform Simple Reaction Time sub-test of ANAM-SRT test. They will be asked to click the mouse button every time they see an asterisk on the screen. Participants will perform ANAM-SRT 1 and ANAM-SRT 2 in this study.; Other Names: Automated Neuropsychological Assessment Metrics; Other: Level of Alertnesss; Participants will answer questions. This assessment is to assess their alertness level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Measurement of EYE-SYNC Data Immediately After Concussive Event, 2 Days, 7 Days and 14 Days Post Concussive Event.	The EYE-SYNC test will be performed immediately after an impact, 2 days, 7 days and 14 days post impact. The movement of eye will be tracked using EYE-SYNC. The data will be recorded in a surface tablet connected to EYE-SYNC.	Immediate post impact, 2 days, 7 days and 14 days post impact.
Reliability of EYE-SYNC Data	The integrity will be analyzed based on the score obtained from EYE-SYNC device.	Immediate post impact, 2 days, 7 days and 14 days post impact.
Integrity of EYE-SYNC Data	The reliability will be analyzed based on the score obtained from EYE-SYNC.	Immediate post impact, 2 days, 7 days and 14 days post impact.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Sport Concussion Assessment Tool (SCAT-3) Test and EYE-SYNC Score	The SCAT-3 result and EYE-SYNC score will be compared.	Immediate post impact, 2 days, 7 days and 14 days post impact.
Compare ANAM-SRT Test and EYE-SYNC Score	The Automated Neuropsychological Assessment Metrics-Simple Reaction Time (ANAM-SRT) evaluation and EYE-SYNC score will be compared.	Immediate post impact, 2 days, 7 days and 14 days post impact.
Compare DEM Test and EYE-SYNC Score	The Developmental Eye Movement (DEM) assessment and EYE-SYNC score will be compared.	Immediate post impact, 2 days, 7 days and 14 days post impact.

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 A Little, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 19, 2016
• First Posted (Estimate): August 24, 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; Vision; Athletes; Eye-tracking
• Other Study ID Numbers: 20160727