EYE-SYNC Concussion Classification Study

June 23, 2020 updated by: Sync-Think, Inc.
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.

Study Overview

Study Type

Observational

Enrollment (Actual)

1303

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Concussion Evaluation
Adult athletes receiving a clinical evaluation for a suspected concussion after head injury
Evaluation of oculomotor performance using visual presentation and eye tracking analysis
Other Names:
  • SCAT-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics
Time Frame: 3 days
A True Positive and True Negative rate for identifying Concussion as compared to a Clinical Reference standard.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2018

Primary Completion (Actual)

March 23, 2020

Study Completion (Actual)

June 23, 2020

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 25, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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