N/A
Completed N=155
EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 1
Eye-tracking
Source: ClinicalTrials.gov NCT02844543 ↗
Enrolled (actual)
155
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error — -0.6; -0.8 Degrees
Summary
This study will assess the effects of exercise and non-concussive bodily contact on eye-tracking scores collected by the EYE-SYNC eye-tracking device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error |
-0.6; -0.8 | — |
| PRIMARY Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error |
1.2; 1.1; 0.9; 0.8 | — |
| PRIMARY Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain |
0.9; 0.9; 0.8; 0.8 | — |
| SECONDARY Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score |
-0.6 | — |
Eligibility Criteria
Inclusion criteria
- Athletes between the age of 18- 25-years-old.
- 20/30 or better eyesight (corrected vision allowed).
- English fluency.
Exclusion criteria
Note: Under Cohort 1, Athletes that have conditions listed below will not be excluded from the study. They will be enrolled and their subject data will be analyzed separately from subjects who do not endorse any significant medical hx under neurological, eye-sight, or psychiatric categories.
- Clinical diagnosis of a neurological condition including the following: Stroke, Multiple Sclerosis, Epilepsy, Brain Tumor/Cancer, Nystagmus and/or other major neurological condition.
- Clinical diagnosis of any of the following eye-sight abnormalities: Uncorrected Amblyopia, Uncorrected Myopia, Uncorrected Presbyopia, Uncorrected Farsightedness, or Uncorrected Astigmatism.
- Psychiatric history with any of the following:
- Clinical diagnosis of a psychotic disorder, bipolar disorder - lifetime
- Clinical diagnosis of ADHD or ADD - Lifetime
- Clinical diagnosis of major depressive disorder - within last year
- Clinical diagnosis of substance abuse disorder - within last year
- Clinical diagnosis of major anxiety disorder - within last year
MEDICATION
- Requires use of a psychotropic medication.
Data sourced from ClinicalTrials.gov (NCT02844543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.