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

• ClinicalTrials.gov Identifier: NCT02877732
• Recruitment Status: Terminated
• First Posted: August 24, 2016
• Results First Posted: April 30, 2018
• Last Update Posted: May 30, 2018
• Sponsor: Stanford University
• Collaborators: Brain Trauma Foundation; United States Department of Defense; Food and Drug Administration (FDA); U.S. Army Medical Research and Development Command; Department of Health and Human Services
• Information provided by (Responsible Party): Jamshid Ghajar, Stanford University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Eye-tracking	Device: EYE-SYNC eye-tracking; Other: SCAT-3 subtests; Other: DEM; Other: Simple Reaction Time subtest of ANAM-SRT; Other: Level of Alertnesss	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 2
• Study Start Date: July 2016
• Actual Primary Completion Date: April 2017
• Actual Study Completion Date: April 2017

Arms and Interventions

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 Name: Sport Concussion Assessment Tool; Other: DEM; Participant will be asked to read list of numbers out loud from a card; Other Name: 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 Name: 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 Name: Sport Concussion Assessment Tool; Other: DEM; Participant will be asked to read list of numbers out loud from a card; Other Name: 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 Name: Automated Neuropsychological Assessment Metrics; Other: Level of Alertnesss; Participants will answer questions. This assessment is to assess their alertness level.

Outcome Measures

Primary Outcome Measures :

1. Changes in the Measurement of EYE-SYNC Data Immediately After Concussive Event, 2 Days, 7 Days and 14 Days Post Concussive Event. [ Time Frame: Immediate post impact, 2 days, 7 days and 14 days post impact. ]
   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.
2. Reliability of EYE-SYNC Data [ Time Frame: Immediate post impact, 2 days, 7 days and 14 days post impact. ]
   The integrity will be analyzed based on the score obtained from EYE-SYNC device.
3. Integrity of EYE-SYNC Data [ Time Frame: Immediate post impact, 2 days, 7 days and 14 days post impact. ]
   The reliability will be analyzed based on the score obtained from EYE-SYNC.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 25 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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).

Contacts and Locations

Locations

United States, California

University of Southern California

Los Angeles, California, United States, 90089

University of California Santa Barbara

Santa Barbara, California, United States, 93106

United States, Oregon

Oregon State University

Corvallis, Oregon, United States, 97331

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

Stanford University

Brain Trauma Foundation

United States Department of Defense

Food and Drug Administration (FDA)

U.S. Army Medical Research and Development Command

Department of Health and Human Services

Investigators

• Principal Investigator: Jessica A Little, PhD; Stanford University

  Study Documents (Full-Text)

Documents provided by Jamshid Ghajar, Stanford University:

Study Protocol and Statistical Analysis Plan  [PDF] April 12, 2016

More Information

• Responsible Party: Jamshid Ghajar, Clinical Professor of Neurosurgery, Stanford University
• ClinicalTrials.gov Identifier: NCT02877732
• Other Study ID Numbers: 20160727
• First Posted: August 24, 2016
• Results First Posted: April 30, 2018
• Last Update Posted: May 30, 2018
• Last Verified: April 2018

Keywords provided by Jamshid Ghajar, Stanford University:

Concussion; Athletes; Eye-tracking; Vision