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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
Sponsor:
Information provided by (Responsible Party):
Mark Ettenhofer, 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).

Condition or disease
Traumatic Brain Injury

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 Type : Observational
Actual Enrollment : 183 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
TBI Group
Adults (civilian or military) with a history of one or more brain injuries / concussions.
Control Group
Healthy adults (civilian or military) with no history of brain injury.



Primary Outcome Measures :
  1. Performance on the eye tracking measures [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Psychological symptoms [ Time Frame: Baseline ]
  2. Performance on the neurocognitive assessment battery [ Time Frame: Baseline ]
  3. Post-concussive symptoms [ Time Frame: Baseline (and telephone follow-up, for TBI group) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The population to be studied will include civilians and military personnel with and without a history of traumatic brain injury / concussion.
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Maryland
USUHS
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Investigators
Principal Investigator: Mark Ettenhofer, Ph.D Uniformed Services University of the Health Sciences

Responsible Party: Mark Ettenhofer, Assistant Professor, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT01552577     History of Changes
Other Study ID Numbers: R072LP-SS3
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: March 2016

Keywords provided by Mark Ettenhofer, Uniformed Services University of the Health Sciences:
Post-Concussion Syndrome
Concussion
Brain Injury
TBI
Military Personnel
Eye-tracking
Neurocognitive Function
Assessment

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System