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CompletedNCT04381767Updated Jun 25, 2020

EYE-SYNC Concussion Classification Study

An observational study in Concussion, Mild, Concussion; Eye and Concussion, Brain, sponsored by Sync-Think, Inc.. Completed at 1 site in United States. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2020-06-25.

Sponsored by Sync-Think, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
1,303
Ages
17 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion evaluation.

02

Conditions studied

  • Concussion, Mild
  • Concussion; Eye
  • Concussion, Brain
  • Concussion, Severe
  • Brain Injuries
  • Concussion, Cerebral
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 1,303 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Sync-Think, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will include all patients evaluated for potential traumatic brain injury presenting to the sports medicine clinicians in an athletic environment.

Inclusion criteria

  • Men and women actively engaged in competitive athletics
  • Eye tracking measurements and SCAT5 evaluations are collected within 3-day window
  • Eye tracking measurements and SCAT5 evaluations are collected within 3 days of injury

Exclusion criteria

Exclusion Criteria:

  • Prior enrollment (subjects may only enroll once)
  • POOR eye tracking data quality
  • Subjects without reported injury detailing alteration of consciousness (AOC) or altered mental status (AMS) defined as self-report, witness report or the following responses to the SCAT5 SSS: "Difficulty Remembering" ≥ 4 or "Confusion" ≥ 4, or scored less than 23 on the SCAT5 Standardized Assessment of Concussion (SAC) or greater than 25 on the SCAT5 Symptom Severity Score (SSS)
  • EYE-SYNC smooth pursuit standard deviation of tangential error (SDTE) variance scores \< 2.0
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
1,303 participants (actual)
Patient registry
No

Groups and cohorts

  • Concussion Evaluation

    Adult athletes receiving a clinical evaluation for a suspected concussion after head injury

    Device: EYE-SYNC

Interventions

  • DeviceEYE-SYNC

    Evaluation of oculomotor performance using visual presentation and eye tracking analysis

    Also known as: SCAT-5

06

What researchers measure

Primary outcomes

  1. A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics

    A True Positive and True Negative rate for identifying Concussion as compared to a Clinical Reference standard.

    Time frame: 3 days

07

Study locations

1 site
  • Sync-Think, Inc.
    Palo Alto, California 94306, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04381767
Lead sponsor
Sync-Think, Inc.
Responsible party
Sponsor
First posted
May 11, 2020
Start date
Dec 19, 2018
Primary completion
Mar 23, 2020
Completion
Jun 23, 2020
Last update
Jun 25, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Sync-Think, Inc.

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