Eye-trackingETA-TVNCT02877732
EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 2
A study testing EYE-SYNC eye-tracking, SCAT-3 subtests and DEM in people with Eye-tracking, run by Stanford University at 4 sites in United States.
Trial summary
This is a prospective multi-center cohort feasibility and exploratory study. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye-tracking
- What is being tested?
- EYE-SYNC eye-tracking, SCAT-3 subtests and DEM
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
- 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"
- Physical Signs:
- Balance (Leg Stances): Number of Error(s) on any of the following 7 subtests classifies a subject as concussed.
- 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:
- 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
- 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.
- Immediate Memory Recall Total Score = less than 13 words recalled.
Who cannot join
- 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
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- 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).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Oregon State University
Corvallis, Oregon, 97331
University of Southern California
Los Angeles, California, 90089
University of Utah
Salt Lake City, Utah, 84112
University of California Santa Barbara
Santa Barbara, California, 93106
About this study
This is a prospective multi-center cohort feasibility and exploratory study.
Read the 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
- Being tested
- EYE-SYNC eye-tracking, SCAT-3 subtests, DEM, Simple Reaction Time subtest of ANAM-SRT, Level of Alertnesss
- Keywords
- Concussion, Athletes, Eye-tracking, Vision
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYE-SYNC eye-trackingDevice
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 subtestsOther
Also called Sport Concussion Assessment Tool
Following subtests of SCAT-3 will be administered to the participant: Symptom, Balance, Orientation and Immediate memory
DEMOther
Also called Developmental Eye Movement
Participant will be asked to read list of numbers out loud from a card
Simple Reaction Time subtest of ANAM-SRTOther
Also called Automated Neuropsychological Assessment Metrics
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 AlertnesssOther
Participants will answer questions. This assessment is to assess their alertness level.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: EYE-SYNC eye-tracking; Other: SCAT-3 subtests; Other: DEM; Other: Simple Reaction Time subtest of ANAM-SRT; Other: Level of Alertnesss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
The SCAT-3 result and EYE-SYNC score will be compared.
Measured: Immediate post impact, 2 days, 7 days and 14 days post impact.
Compare ANAM-SRT Test and EYE-SYNC Score
The Automated Neuropsychological Assessment Metrics-Simple Reaction Time (ANAM-SRT) evaluation and EYE-SYNC score will be compared.
Measured: Immediate post impact, 2 days, 7 days and 14 days post impact.
Compare DEM Test and EYE-SYNC Score
The Developmental Eye Movement (DEM) assessment and EYE-SYNC score will be compared.
Measured: Immediate post impact, 2 days, 7 days and 14 days post impact.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: The funding sponsor elected to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eye-trackingStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Trauma Foundation, United States Department of Defense, Food and Drug Administration (FDA), U.S. Army Medical Research and Development Command, Department of Health and Human Services
- Responsible party
- Principal investigator, Jamshid Ghajar, Stanford University
- Investigators
- Jessica A Little, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877732
- Sponsor's protocol ID
- 20160727
- Acronym
- ETA-TV
- Status last verified
- Apr 2018
- First submitted
- 9 Aug 2016
- Last updated
- 30 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 2
- ClinicalTrials.gov ID
- NCT02877732
- Acronym / sponsor ID
- ETA-TV / 20160727
- Conditions
- Eye-tracking
- Keywords
- Concussion, Athletes, Eye-tracking, Vision
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The funding sponsor elected to terminate the study.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Brain Trauma Foundation, United States Department of Defense, Food and Drug Administration (FDA), U.S. Army Medical Research and Development Command, Department of Health and Human Services
- Study start
- Jul 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Posted 30 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussed Subject | Experimental | Device: EYE-SYNC eye-tracking, Other: SCAT-3 subtests, Other: DEM, Other: Simple Reaction Time subtest of ANAM-SRT, Other: Level of AlertnesssEYE-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. |
| Control Subject | Active comparator | Device: EYE-SYNC eye-tracking, Other: SCAT-3 subtests, Other: DEM, Other: Simple Reaction Time subtest of ANAM-SRT, Other: Level of AlertnesssEYE-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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (27 listed)
- Athletes between the age of 18- 25-years-old.
- 20/30 or better eyesight (corrected vision allowed).
- English fluency.
- 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 (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.
Key exclusion criteria (11 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EYE-SYNC eye-trackingThe 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. | Device | Concussed Subject, Control Subject |
| SCAT-3 subtestsAlso: Sport Concussion Assessment ToolFollowing subtests of SCAT-3 will be administered to the participant: Symptom, Balance, Orientation and Immediate memory | Other | Concussed Subject, Control Subject |
| DEMAlso: Developmental Eye MovementParticipant will be asked to read list of numbers out loud from a card | Other | Concussed Subject, Control Subject |
| Simple Reaction Time subtest of ANAM-SRTAlso: Automated Neuropsychological Assessment MetricsParticipants 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. | Other | Concussed Subject, Control Subject |
| Level of AlertnesssParticipants will answer questions. This assessment is to assess their alertness level. | Other | Concussed Subject, Control Subject |
Primary outcome
Changes in the Measurement of EYE-SYNC Data Immediately After Concussive Event, 2 Days, 7 Days and 14 Days Post Concussive Event.
Time frame: Immediate post impact, 2 days, 7 days and 14 days post impact.
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.
Reliability of EYE-SYNC Data
Time frame: Immediate post impact, 2 days, 7 days and 14 days post impact.
The integrity will be analyzed based on the score obtained from EYE-SYNC device.
Integrity of EYE-SYNC Data
Time frame: Immediate post impact, 2 days, 7 days and 14 days post impact.
The reliability will be analyzed based on the score obtained from EYE-SYNC.
3 secondary outcomes
Compare Sport Concussion Assessment Tool (SCAT-3) Test and EYE-SYNC Score
Time frame: Immediate post impact, 2 days, 7 days and 14 days post impact.
Compare ANAM-SRT Test and EYE-SYNC Score
Time frame: Immediate post impact, 2 days, 7 days and 14 days post impact.
Compare DEM Test and EYE-SYNC Score
Time frame: Immediate post impact, 2 days, 7 days and 14 days post impact.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica A Little, PhD principal investigator
Stanford University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EYE-SYNC eye-tracking, SCAT-3 subtests and DEM in people with Eye-tracking, run by Stanford University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Measurement of EYE-SYNC Data Immediately After Concussive Event, 2 Days, 7 Days and 14 Days Post Concussive Event. (time frame: Immediate post impact, 2 days, 7 days and 14 days post impact.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.