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

Stopped early · Not applicable

Conditions studied: Eye-tracking

In brief

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

Key facts

Study ID

NCT02877732

Run by

Stanford University

People needed

12

Starts

2016-07-01

Expected to finish

2017-04-01

Last updated by the study team

2018-05-30

Who can join

Age: 18 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• Headaches
• Nausea or Vomiting
• Dizziness
• Balance Problems
• Blurred Vision
• Feeling Slowed Down
• Feeling like "in a fog"
• "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
• If step off the line;
• Separation between heel and toe
• Touch/grab the examiner or an object

You may not qualify if…

• 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:
• Clinical diagnosis of a psychotic disorder, bipolar disorder - lifetime
• Clinical diagnosis of ADHD or ADD - Lifetime
• Clinical diagnosis of major depressive disorder - within last year
• Clinical diagnosis of substance abuse disorder - within last year
• Clinical diagnosis of major anxiety disorder - within last year
• MEDICATION
• 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).

Where it is running

• University of Southern California — Los Angeles, California, United States
• University of California Santa Barbara — Santa Barbara, California, United States
• Oregon State University — Corvallis, Oregon, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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