NCT02877732

EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 2

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

This is a prospective multi-center cohort feasibility and exploratory study.

Detailed description

Investigators propose to prospectively study a cohort of 18-25-year-old athletes to establish the reliability of EYE-SYNC data and the utility of the EYE-SYNC eye-tracking device as a sideline concussion assessment tool. The clinical research study will be conducted to 1) determine if eye-tracking, assessed on the sideline by EYE-SYNC eye-tracking device, is a potential marker of injury that can be used in conjunction with other sideline evaluations to inform decisions regarding removal of athletes from play and 2) to use the EYE-SYNC goggle data as a post- injury recovery monitor.

Conditions

• Eye-tracking

Interventions

Type	Name	Description
DEVICE	EYE-SYNC eye-tracking	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.
OTHER	SCAT-3 subtests	Following subtests of SCAT-3 will be administered to the participant: Symptom, Balance, Orientation and Immediate memory
OTHER	DEM	Participant will be asked to read list of numbers out loud from a card
OTHER	Simple Reaction Time subtest of ANAM-SRT	Participants will perform Simple Reaction Time sub-test of ANAM-SRT test. They will be asked to click the mouse button every time they see an asterisk on the screen. Participants will perform ANAM-SRT 1 and ANAM-SRT 2 in this study.
OTHER	Level of Alertnesss	Participants will answer questions. This assessment is to assess their alertness level.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2016-08-24
• Last updated: 2018-05-30
• Results posted: 2018-04-30

Locations

4 sites across 1 country: United States