EYE-SYNC Concussion Classification Study
Completed
Conditions studied: Concussion, Mild, Concussion; Eye, Concussion, Brain, Concussion, Severe, Brain Injuries, Concussion, Cerebral
In brief
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.
Key facts
- Study ID
- NCT04381767
- Run by
- Sync-Think, Inc.
- People needed
- 1303
- Starts
- 2018-12-19
- Expected to finish
- 2020-06-23
- Last updated by the study team
- 2020-06-25
Who can join
Age: 17 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sync-Think, Inc. — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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