EYE-SYNC Concussion Classification Study

Sync-Think

Status: Completed

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

Treatments: Device: EYE-SYNC

Study type: Observational

Funder types: Industry

Identifiers

NCT04381767

EYESYNCCCV2020

Details and patient eligibility

About

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.

Enrollment: 1,303 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,303 participants in 1 patient group

Concussion Evaluation

Description:

Adult athletes receiving a clinical evaluation for a suspected concussion after head injury

Treatment:

Device: EYE-SYNC