EYE-SYNC Concussion Classification Study

Sync-Think, Inc.1 site in 1 country1,303 target enrollmentDecember 19, 2018

ConditionsConcussion, Mild Concussion; Eye Concussion, Brain Concussion, Severe Brain Injuries Concussion, Cerebral

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Concussion, Mild
Sponsor: Sync-Think, Inc.
Enrollment: 1303
Locations: 1
Primary Endpoint: A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 19, 2018

End Date

June 23, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Sync-Think, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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