Clinical trial NCT02844543: EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 1
Official title: EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye-tracking
Keywords: concussion, eye-tracking, athletes, 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: 2016-07-26
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will assess the effects of exercise and non-concussive bodily contact on eye-tracking scores collected by the EYE-SYNC eye-tracking device.

Detailed description: The investigators propose to prospectively study a cohort of 18-25-year-old athletes. Athletes will be tested with the EYE-SYNC eye-tracking device prior to the start of an athletic practice or competition (pre-test) and then after the conclusion of the practice/competition (post-test). The investigators hope to understand if eye-tracking scores are effected by exercise and non-concussive bodily contact commonly incurred during athletic play.

Eligibility criteria: Inclusion criteria

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

Exclusion criteria

Note: Under Cohort 1, Athletes that have conditions listed below will not be excluded from the study. They will be enrolled and their subject data will be analyzed separately from subjects who do not endorse any significant medical hx under neurological, eye-sight, or psychiatric categories.

* 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.

Primary outcomes:
measure: Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error
timeFrame: Up to 6 hours
measure: Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error
timeFrame: Up to 6 hours
measure: Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score
timeFrame: Day of study/event (up to 6 hours)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Jessica Little, PhD
role: PRINCIPAL_INVESTIGATOR
References: