Status:
COMPLETED
EYE-SYNC Concussion Classification Study
Lead Sponsor:
Sync-Think, Inc.
Conditions:
Concussion, Mild
Concussion; Eye
Eligibility:
All Genders
17+ years
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 sp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 23 2020
Estimated Enrollment :
1303 Patients enrolled
Trial Details
Trial ID
NCT04381767
Start Date
December 19 2018
End Date
June 23 2020
Last Update
June 25 2020
Active Locations (1)
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1
Sync-Think, Inc.
Palo Alto, California, United States, 94306