The RETINA Project: Reliable Eye Tracking in Neurocognitive Assessment of Traumatic Brain Injury (RETINA)
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|ClinicalTrials.gov Identifier: NCT01552577|
Recruitment Status : Terminated (Expiration of funding)
First Posted : March 13, 2012
Last Update Posted : March 11, 2016
|Condition or disease|
|Traumatic Brain Injury|
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|
|Actual Enrollment :||183 participants|
|Observational Model:||Case Control|
|Official Title:||Eye Tracking Indicators of Neurocognitive Status After Traumatic Brain Injury|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||October 2017|
Adults (civilian or military) with a history of one or more brain injuries / concussions.
Healthy adults (civilian or military) with no history of brain injury.
- Performance on the eye tracking measures [ Time Frame: Baseline ]
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552577
|United States, Maryland|
|Bethesda, Maryland, United States, 20814|
|Principal Investigator:||Mark Ettenhofer, Ph.D||Uniformed Services University of the Health Sciences|