The RETINA Project: Reliable Eye Tracking in Neurocognitive Assessment of Traumatic Brain Injury

Terminated

• Conditions: Traumatic Brain Injury

• Registration Number: NCT01552577
• Lead Sponsor: Uniformed Services University of the Health Sciences

Brief Summary

The purpose of this study is to develop and validate eye-tracking measures that can be used to evaluate neurocognitive dysfunction among individuals with traumatic brain injury (TBI).

Detailed Description

This study will evaluate a novel method of neurocognitive assessment using computerized eye tracking. This method involves looking at targets on a computer screen while an eye-tracking system records eye movements and changes in pupil diameter in response to the presentation of the targets.

Performance on the eye tracking measures will be evaluated to identify potential effects of neural injury on cognitive performance. Data from individuals with and without a history of brain injury will be used to standardize the eye tracking measure.

Participants will also complete a short interview and several self report measures, including information about demographic characteristics, medical history, and psychological symptoms, along with a series of neuropsychological/cognitive measures that are already well established. Performance on eye tracking measures will then be compared to performance on these conventional cognitive tests to allow comparison of the different measures.

All participants will complete one visit to the laboratory at USUHS in Bethesda, MD. This visit will take approximately 2.5 hours. Participants without a history of TBI may be asked to return for a 30 minute follow-up session in order to measure the reliability of the eye tracking system. Participants with a history of TBI will complete a 10 minute telephone follow-up 6 and 12 months after their visit.

Compensation is available for civilians who are not employed by the Federal government.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-13
• Primary Completion: 2015-08
• Study Completion: 2017-10
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-14
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance on the eye tracking measures	Baseline

Secondary Outcome Measures

Name	Time	Method
Psychological symptoms	Baseline
Post-concussive symptoms	Baseline (and telephone follow-up, for TBI group)
Performance on the neurocognitive assessment battery	Baseline

Trial Locations

Locations (1)

USUHS; 🇺🇸 Bethesda, Maryland, United States