Clinical trial NCT02877732: EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 2
Official title: EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eye-tracking
Keywords: Concussion
Athletes
Eye-tracking
Vision
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Brain Trauma Foundation
name: United States Department of Defense
name: Food and Drug Administration (FDA)
name: U.S. Army Medical Research and Development Command
name: Department of Health and Human Services
First posted: 2016-08-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Eligibility 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).

Primary outcomes:
measure: Changes in the Measurement of EYE-SYNC Data Immediately After Concussive Event, 2 Days, 7 Days and 14 Days Post Concussive Event.
timeFrame: Immediate post impact, 2 days, 7 days and 14 days post impact.
measure: Reliability of EYE-SYNC Data
timeFrame: Immediate post impact, 2 days, 7 days and 14 days post impact.
measure: Integrity of EYE-SYNC Data
timeFrame: Immediate post impact, 2 days, 7 days and 14 days post impact.
Secondary outcomes:
measure: Compare Sport Concussion Assessment Tool (SCAT-3) Test and EYE-SYNC Score
timeFrame: Immediate post impact, 2 days, 7 days and 14 days post impact.
measure: Compare ANAM-SRT Test and EYE-SYNC Score
timeFrame: Immediate post impact, 2 days, 7 days and 14 days post impact.
measure: Compare DEM Test and EYE-SYNC Score
timeFrame: Immediate post impact, 2 days, 7 days and 14 days post impact.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Santa Barbara
country: United States
facility: University of California Santa Barbara
state: California
city: Corvallis
country: United States
facility: Oregon State University
state: Oregon
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Stanford University
name: Jessica A Little, PhD
role: PRINCIPAL_INVESTIGATOR
References: