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

Uniformed Services University of the Health Sciences183 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

183

Conditions

Traumatic Brain Injury

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria (Control Group): * 18 years of age or older * No history of brain injury or concussion * Fluency and literacy in English * Can effectively communicate verbally * Willing and able to provide written informed consent * Obtains signed permission to participate from supervisor and/or brigade commander (federal civilian employees and active duty military personnel only). Exclusion Criteria (Control Group) * Impaired or fluctuating level of consciousness / arousal * Any medical condition that could impair cognitive abilities (e.g. muscular dystrophy, multiple sclerosis, psychosis) * History of any neurological conditions such as brain tumor, brain infection, seizure or stroke * Any visual impairment that is not corrected by glasses/contacts * Motor impairment or amputation of one or both upper extremities Inclusion Criteria (TBI Group): * 18 years of age or older * History of one or more brain injuries / concussion * Fluency and literacy in English * Can effectively communicate verbally * Willing and able to provide written informed consent * Obtains signed permission to participate from supervisor and/or brigade commander (federal civilian employees and active duty military personnel only). Exclusion Criteria (TBI Group) * Impaired or fluctuating level of consciousness / arousal * Any medical condition that could impair cognitive abilities (e.g. muscular dystrophy, multiple sclerosis, psychosis), other than TBI * History of any neurological conditions (such as brain tumor, brain infection, seizure or stroke) that was NOT associated with or resulting from traumatic brain injury * Any visual impairment that is not corrected by glasses/contacts * Motor impairment or amputation of one or both upper extremities

Locations (1)

USUHS

Bethesda, Maryland, United States

Outcomes

Primary Outcomes

Performance on the eye tracking measures

Time frame: Baseline

Secondary Outcomes

Psychological symptoms

Time frame: Baseline

Performance on the neurocognitive assessment battery

Time frame: Baseline

Post-concussive symptoms

Time frame: Baseline (and telephone follow-up, for TBI group)

Data from ClinicalTrials.gov

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