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

NCT01552577 | Terminated DMC

• 1 other identifier: R072LP-SS3
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury

Keywords

Post-Concussion Syndrome; Concussion; Brain Injury; TBI; Military Personnel; Eye-tracking; Neurocognitive Function; Assessment

Outcome Measures

Primary Outcomes (1)

• Performance on the eye tracking measures

  Baseline

Secondary Outcomes (3)

• Psychological symptoms

  Baseline

• Performance on the neurocognitive assessment battery

  Baseline

• Post-concussive symptoms

  Baseline (and telephone follow-up, for TBI group)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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).
• 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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead

Study Sites (1)

USUHS

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Post-Concussion Syndrome; Brain Concussion; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Mark Ettenhofer, Ph.D

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 13, 2012
• Study Start: October 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2017
• Last Updated: December 17, 2018

Record last verified: 2018-12

Locations

US (1)