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

Traumatic Brain Injury Clinical Trial

— RETINA  

Official title:

Eye Tracking Indicators of Neurocognitive Status After Traumatic Brain Injury

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01552577
• Other study ID #: R072LP-SS3
• Status: Terminated
• Start date: October 2010
• Est. completion date: October 2017

Study information

• Verified date: December 2018
• Source: Uniformed Services University of the Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 183
• Est. completion date: October 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	USUHS	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Uniformed Services University of the Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on the eye tracking measures		Baseline
Secondary	Psychological symptoms		Baseline
Secondary	Performance on the neurocognitive assessment battery		Baseline
Secondary	Post-concussive symptoms		Baseline (and telephone follow-up, for TBI group)