The RETINA Project: Reliable Eye Tracking in Neurocognitive Assessment of Traumatic Brain Injury
NCT ID: NCT01552577
Last Updated: 2018-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
183 participants
OBSERVATIONAL
2010-10-31
2017-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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TBI Group
Adults (civilian or military) with a history of one or more brain injuries / concussions.
No interventions assigned to this group
Control Group
Healthy adults (civilian or military) with no history of brain injury.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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).
* 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
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Uniformed Services University of the Health Sciences
FED
Responsible Party
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Mark Ettenhofer
Assistant Professor
Principal Investigators
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Mark Ettenhofer, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Uniformed Services University of the Health Sciences
Locations
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USUHS
Bethesda, Maryland, United States
Countries
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Other Identifiers
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R072LP-SS3
Identifier Type: -
Identifier Source: org_study_id