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

NCT02877732 | Terminated Results

• 1 other identifier: 20160727
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Eye-tracking

Keywords

Concussion; Athletes; Eye-tracking; Vision

Outcome Measures

Primary Outcomes (3)

• Changes in the Measurement of EYE-SYNC Data Immediately After Concussive Event, 2 Days, 7 Days and 14 Days Post Concussive Event.

  The EYE-SYNC test will be performed immediately after an impact, 2 days, 7 days and 14 days post impact. The movement of eye will be tracked using EYE-SYNC. The data will be recorded in a surface tablet connected to EYE-SYNC.

  Immediate post impact, 2 days, 7 days and 14 days post impact.

• Reliability of EYE-SYNC Data

  The integrity will be analyzed based on the score obtained from EYE-SYNC device.

  Immediate post impact, 2 days, 7 days and 14 days post impact.

• Integrity of EYE-SYNC Data

  The reliability will be analyzed based on the score obtained from EYE-SYNC.

  Immediate post impact, 2 days, 7 days and 14 days post impact.

Secondary Outcomes (3)

• Compare Sport Concussion Assessment Tool (SCAT-3) Test and EYE-SYNC Score

  Immediate post impact, 2 days, 7 days and 14 days post impact.

• Compare ANAM-SRT Test and EYE-SYNC Score

  Immediate post impact, 2 days, 7 days and 14 days post impact.

• Compare DEM Test and EYE-SYNC Score

  Immediate post impact, 2 days, 7 days and 14 days post impact.

Study Arms (2)

Concussed Subject

EXPERIMENTAL

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.

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

Control Subject

ACTIVE COMPARATOR

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.

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

Interventions

EYE-SYNC eye-tracking 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.

Concussed Subject; Control Subject

SCAT-3 subtests OTHER

Following subtests of SCAT-3 will be administered to the participant: Symptom, Balance, Orientation and Immediate memory

Also known as: Sport Concussion Assessment Tool

Concussed Subject; Control Subject

DEM OTHER

Participant will be asked to read list of numbers out loud from a card

Also known as: Developmental Eye Movement

Concussed Subject; Control Subject

Simple Reaction Time subtest of ANAM-SRT OTHER

Participants will perform Simple Reaction Time sub-test of ANAM-SRT test. They will be asked to click the mouse button every time they see an asterisk on the screen. Participants will perform ANAM-SRT 1 and ANAM-SRT 2 in this study.

Also known as: Automated Neuropsychological Assessment Metrics

Concussed Subject; Control Subject

Level of Alertnesss OTHER

Participants will answer questions. This assessment is to assess their alertness level.

Concussed Subject; Control Subject

Eligibility Criteria

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

You may qualify if:

• Both CCS and CTR must meet the following 3 criteria:
• Athletes between the age of 18- 25-years-old.
• /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

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).

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 (4)

University of Southern California

Los Angeles, California, 90089, United States

Location

University of California Santa Barbara

Santa Barbara, California, 93106, United States

Location

Oregon State University

Corvallis, Oregon, 97331, United States

Location

University of Utah

Salt Lake City, Utah, 84112, 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
• Organization: Stanford Concussion and Brain Performance Center/ Stanford Emergency Medicine

jghajar@stanford.edu

(650) 725-5562

Study Officials

• Jessica A Little, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 24, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 30, 2018
• Results First Posted: April 30, 2018

Record last verified: 2018-04

Locations

US (4)