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

Eye Tracking Indicators of Neurocognitive Status After Traumatic Brain Injury

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).

Study Overview

• Status: Terminated
• Conditions: 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
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • USUHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Performance on the eye tracking measures	Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Uniformed Services University of the Health Sciences
• Investigators: Principal Investigator: Mark Ettenhofer, Ph.D, Uniformed Services University of the Health Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: March 8, 2012
• First Submitted That Met QC Criteria: March 12, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Actual): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Concussion; Assessment; TBI; Brain Injury; Neurocognitive Function; Post-Concussion Syndrome; Eye-tracking; Military Personnel
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: R072LP-SS3