Eye-tracking
Conditions
Keywords
concussion, eye-tracking, athletes, vision
Brief 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.
Detailed description
The investigators propose to prospectively study a cohort of 18-25-year-old athletes. Athletes will be tested with the EYE-SYNC eye-tracking device prior to the start of an athletic practice or competition (pre-test) and then after the conclusion of the practice/competition (post-test). The investigators hope to understand if eye-tracking scores are effected by exercise and non-concussive bodily contact commonly incurred during athletic play.
Interventions
DEVICEEYE-SYNC eye-tracking device
The EYE-SYNC® portable eye-tracking system. The eye tracker is a handheld isolated display environment with embedded eye tracking sensors. The eye tracker is connected to a high-performance Windows tablet though a customized docking station. Included accessories with EYE-SYNC are a U.S. tablet power supply adapter and disposable sanitary masks. Participants are asked to follow a dot with their eyes, as the dot moves on the screen of the EYE-SYNC device.
OTHERSCAT-3
The Symptom subtest of SCAT-3 assessment tool will be administered to participants.
DEVICEDesktop Eye-Tracker
Eye movements are recorded with an eye tracking system (Desktop Eye-Tracker, Eyelink CR, SR Research) with up to 1000 Hz temporal resolution. The target stimulus is presented on a computer screen approximately 50 cm from the participant. Participants are asked to follow a dot with their eyes, as the dot moves on the monitor screen of the desk-top eye-tracking device.
Sponsors
Brain Trauma Foundation
United States Department of Defense
Food and Drug Administration (FDA)
U.S. Army Medical Research and Development Command
Department of Health and Human Services
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
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: 1. Clinical diagnosis of a psychotic disorder, bipolar disorder - lifetime 2. Clinical diagnosis of ADHD or ADD - Lifetime 3. Clinical diagnosis of major depressive disorder - within last year 4. Clinical diagnosis of substance abuse disorder - within last year 5. Clinical diagnosis of major anxiety disorder - within last year MEDICATION 6. Requires use of a psychotropic medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error | Up to 6 hours | The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Phase error is defined as the difference in degrees between movement of the target and the movement of the eye. Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target. |
| Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error | Up to 6 hours | The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Tangential and radial error are defined as degrees of variation in eye tracking along a circular path (tangential) and at 90 degrees to the tangential path (radial). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target. |
| Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain | Up to 6 hours | The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Vertical and horizontal gain are defined as the ratio of velocity (velocity of the eye:velocity of the target). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score | Day of study/event (up to 6 hours) | Change in SCAT-3 SAC score before and after practice or game is reported. The SAC score is based on the following assessments: number of symptoms (22 points), symptom severity (132 points), orientation (5 points), immediate memory (15 points), concentration (5 points), and delayed recall (5 points). Scores are summed for a possible range of 0 to 184, with lower scores corresponding to fewer concussion symptoms, and higher scores corresponding to more concussion symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Athletes Participants were tested with the EYE-SYNC eye-tracking device, the Desktop Eye-tracker, and SCAT-3 Symptom subtest. | 150 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet eligibility criteria | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Athletes |
|---|---|
| Age, Continuous | 19.8 years STANDARD_DEVIATION 1.3 |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 155 |
| other Total, other adverse events | 0 / 155 |
| serious Total, serious adverse events | 0 / 155 |
Outcome results
Primary
Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error
The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Phase error is defined as the difference in degrees between movement of the target and the movement of the eye. Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.
Time frame: Up to 6 hours
Population: Participants with evaluable data at the respective time point were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Athletes | Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error | Prior to practice/game | -0.6 Degrees | Standard Deviation 4 |
| Athletes | Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error | After practice/game | -0.8 Degrees | Standard Deviation 0.5 |
Primary
Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error
The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Tangential and radial error are defined as degrees of variation in eye tracking along a circular path (tangential) and at 90 degrees to the tangential path (radial). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.
Time frame: Up to 6 hours
Population: Participants with evaluable data at the respective time point were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Athletes | Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error | Tangential: after practice/game | 1.1 Degrees of variation | Standard Deviation 0.7 |
| Athletes | Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error | Radial: prior to practice/game | 0.9 Degrees of variation | Standard Deviation 0.4 |
| Athletes | Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error | Tangential: prior to practice/game | 1.2 Degrees of variation | Standard Deviation 0.8 |
| Athletes | Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error | Radial: after practice/game | 0.8 Degrees of variation | Standard Deviation 0.5 |
Primary
Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain
The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Vertical and horizontal gain are defined as the ratio of velocity (velocity of the eye:velocity of the target). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.
Time frame: Up to 6 hours
Population: Participants with evaluable data at the respective time point were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Athletes | Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain | Horizontal: prior to practice/game | 0.9 Ratio of velocity (degrees per second) | Standard Deviation 0.1 |
| Athletes | Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain | Horizontal: after practice/game | 0.9 Ratio of velocity (degrees per second) | Standard Deviation 0.1 |
| Athletes | Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain | Vertical: prior to practice/game | 0.8 Ratio of velocity (degrees per second) | Standard Deviation 0.1 |
| Athletes | Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain | Vertical: after practice/game | 0.8 Ratio of velocity (degrees per second) | Standard Deviation 0.1 |
Secondary
Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score
Change in SCAT-3 SAC score before and after practice or game is reported. The SAC score is based on the following assessments: number of symptoms (22 points), symptom severity (132 points), orientation (5 points), immediate memory (15 points), concentration (5 points), and delayed recall (5 points). Scores are summed for a possible range of 0 to 184, with lower scores corresponding to fewer concussion symptoms, and higher scores corresponding to more concussion symptoms.
Time frame: Day of study/event (up to 6 hours)
Population: Participants who completed the protocol were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Athletes | Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score | -0.6 units on a scale | Standard Deviation 3.6 |