EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 1

NCT02844543 | Completed Results

• 1 other identifier: 34662
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye-tracking

Keywords

concussion, eye-tracking, athletes, vision

Outcome Measures

Primary Outcomes (3)

• Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error

  The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Phase error is defined as the difference in degrees between movement of the target and the movement of the eye. Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.

  Up to 6 hours

• Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error

  The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Tangential and radial error are defined as degrees of variation in eye tracking along a circular path (tangential) and at 90 degrees to the tangential path (radial). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.

  Up to 6 hours

• Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain

  The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Vertical and horizontal gain are defined as the ratio of velocity (velocity of the eye:velocity of the target). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.

  Up to 6 hours

Secondary Outcomes (1)

• Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score

  Day of study/event (up to 6 hours)

Study Arms (1)

Athletes

EXPERIMENTAL

Participants will be evaluated using the EYE-SYNC eye-tracking device, Desktop Eye-Tracker, and Sport Concussion Assessment Tool (SCAT-3) tool.

Device: EYE-SYNC eye-tracking device; Other: SCAT-3; Device: Desktop Eye-Tracker

Interventions

EYE-SYNC eye-tracking device DEVICE

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.

Athletes

SCAT-3 OTHER

The Symptom subtest of SCAT-3 assessment tool will be administered to participants.

Athletes

Desktop Eye-Tracker DEVICE

Eye movements are recorded with an eye tracking system (Desktop Eye-Tracker, Eyelink CR, SR Research) with up to 1000 Hz temporal resolution. The target stimulus is presented on a computer screen approximately 50 cm from the participant. Participants are asked to follow a dot with their eyes, as the dot moves on the monitor screen of the desk-top eye-tracking device.

Athletes

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Stanford University: lead
• Brain Trauma Foundation: collaborator
• United States Department of Defense: collaborator
• Food and Drug Administration (FDA): collaborator
• U.S. Army Medical Research and Development Command: collaborator
• Department of Health and Human Services: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Results Point of Contact

• Title: Dr. Jamshid Ghajar, MD, PhD
• Organization: Stanford University

acrevelt@stanford.edu

(650) 725-5562

Study Officials

• Jessica Little, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Neurosurgery

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 26, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 30, 2018
• Results First Posted: April 30, 2018

Record last verified: 2018-04

Locations

US (1)