Brain Injuries, Concussion, Brain, Concussion, Cerebral, Concussion; Eye, Concussion, Mild, Concussion, Severe
Conditions
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.
Interventions
DEVICEEYE-SYNC
Evaluation of oculomotor performance using visual presentation and eye tracking analysis
Sponsors
Sync-Think, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics | 3 days | A True Positive and True Negative rate for identifying Concussion as compared to a Clinical Reference standard. |
Countries
United States
Outcome results
None listed