EYE-SYNC Concussion Classification Study

Brain Injuries Clinical Trial

Official title:

EYE-SYNC Concussion Classification Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04381767
• Other study ID #: EYESYNCCCV2020
• Status: Completed
• Start date: December 19, 2018
• Est. completion date: June 23, 2020

Study information

• Verified date: June 2020
• Source: Sync-Think, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1303
• Est. completion date: June 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• EYE-SYNC
Evaluation of oculomotor performance using visual presentation and eye tracking analysis

Locations

Country	Name	City	State
United States	Sync-Think, Inc.	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Sync-Think, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days