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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Eye Tracking Indicators of Neurocognitive Status After Traumatic Brain Injury

Conditions
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Traumatic Brain Injury

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TBI Group<br>Adults (civilian or military) with a history of one or more brain injuries / concussions. | |
| Control Group<br>Healthy adults (civilian or military) with no history of brain injury. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on the eye tracking measures |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological symptoms |  | Baseline | 
| Performance on the neurocognitive assessment battery |  | Baseline | 
| Post-concussive symptoms |  | Baseline (and telephone follow-up, for TBI group) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Concussion Syndrome, Concussion, Brain Injury, TBI, Military Personnel, Eye-tracking, Neurocognitive Function, Assessment