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

NCT ID: NCT02877732

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-04-30

Brief Summary

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

Detailed 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.

Conditions

Eye-tracking

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Concussed Subject

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.

Group Type: EXPERIMENTAL

EYE-SYNC eye-tracking

Intervention Type: 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.

SCAT-3 subtests

Intervention Type: OTHER

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

DEM

Intervention Type: OTHER

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

Simple Reaction Time subtest of ANAM-SRT

Intervention Type: 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.

Level of Alertnesss

Intervention Type: OTHER

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

Control Subject

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.

Group Type: ACTIVE_COMPARATOR

EYE-SYNC eye-tracking

Intervention Type: 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.

SCAT-3 subtests

Intervention Type: OTHER

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

DEM

Intervention Type: OTHER

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

Simple Reaction Time subtest of ANAM-SRT

Intervention Type: 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.

Level of Alertnesss

Intervention Type: OTHER

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

Interventions

EYE-SYNC eye-tracking

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.

Intervention Type: DEVICE

SCAT-3 subtests

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

Intervention Type: OTHER

DEM

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

Intervention Type: OTHER

Simple Reaction Time subtest of ANAM-SRT

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.

Intervention Type: OTHER

Level of Alertnesss

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

Intervention Type: OTHER

Other Intervention Names

Sport Concussion Assessment Tool; Developmental Eye Movement; Automated Neuropsychological Assessment Metrics

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brain Trauma Foundation

OTHER

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Department of Health and Human Services

FED

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jamshid Ghajar

Clinical Professor of Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica A Little, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20160727

Identifier Type: -

Identifier Source: org_study_id