EYE-SYNC Concussion Classification Study

Sync-Think, Inc.1,303 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,303

Conditions

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

Interventions

EYE-SYNCDEVICE

Evaluation of oculomotor performance using visual presentation and eye tracking analysis

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Sync-Think, Inc.

Palo Alto, California, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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