EYE-SYNC Concussion Classification Study

Completed

• Conditions: Concussion, Brain; Concussion; Eye; Concussion, Severe; Concussion, Cerebral; Brain Injuries; Concussion, Mild
• Interventions: Device: EYE-SYNC

• Registration Number: NCT04381767
• Lead Sponsor: Sync-Think, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-19
• Primary Completion: 2020-03-23
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-11
• Status Verified: 2020-06
• Study Completion: 2020-06-23
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1303

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Concussion Evaluation	EYE-SYNC	Adult athletes receiving a clinical evaluation for a suspected concussion after head injury

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sync-Think, Inc.; 🇺🇸 Palo Alto, California, United States