Clinical trial NCT01552577: The RETINA Project: Reliable Eye Tracking in Neurocognitive Assessment of Traumatic Brain Injury
Official title: Eye Tracking Indicators of Neurocognitive Status After Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Traumatic Brain Injury
Keywords: Post-Concussion Syndrome
Concussion
Brain Injury
TBI
Military Personnel
Eye-tracking
Neurocognitive Function
Assessment
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
First posted: 2012-03-13
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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).

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.

Eligibility 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

Primary outcomes:
measure: Performance on the eye tracking measures
timeFrame: Baseline
Secondary outcomes:
measure: Psychological symptoms
timeFrame: Baseline
measure: Performance on the neurocognitive assessment battery
timeFrame: Baseline
measure: Post-concussive symptoms
timeFrame: Baseline (and telephone follow-up, for TBI group)
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: USUHS
state: Maryland
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Mark Ettenhofer, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: