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

Stanford University

Status: Terminated

Conditions: Eye-tracking

Treatments: Device: EYE-SYNC eye-tracking; Other: DEM; Other: SCAT-3 subtests; Other: Level of Alertnesss; Other: Simple Reaction Time subtest of ANAM-SRT

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02877732

20160727

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Concussed Subject

Experimental group

Description:

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.

Treatment:

Other: Simple Reaction Time subtest of ANAM-SRT

Other: Level of Alertnesss

Other: SCAT-3 subtests

Other: DEM

Device: EYE-SYNC eye-tracking

Control Subject

Active Comparator group

Description:

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.

Treatment:

Other: Simple Reaction Time subtest of ANAM-SRT

Other: Level of Alertnesss

Other: SCAT-3 subtests

Other: DEM

Device: EYE-SYNC eye-tracking