NCT04381767CompletedNot Applicable
EYE-SYNC Concussion Classification Study
Sync-Think, Inc.1 site in 1 country1,303 target enrollmentStarted: December 19, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,303
- Locations
- 1
- Primary Endpoint
- A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics
Time Frame: 3 days
A True Positive and True Negative rate for identifying Concussion as compared to a Clinical Reference standard.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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