Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT00875589
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The study investigates whether the use of eye movement recordings can provide a reliable diagnostic of previously undiagnosed mild traumatic brain injury (blast and impact) in Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans.

Detailed Description

Eye movements are recorded for Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans with mild traumatic brain injury (mTBI) and compared to the eye movements of those without mTBI. By analyzing and characterizing the differences between the two groups, a diagnostic measure of mTBI through the use of eye movements can be developed.

Study Timeline

• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Study Start: 2011-04
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Results First Submitted: 2015-09-10
• Results First Submitted QC: 2015-09-10
• Status Verified: 2015-10
• Results First Posted: 2015-10-08
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• OIF/OEF Veteran;
• Neuropsych diagnosis of MTBI

Exclusion Criteria

• chronically abusing alcohol or illicit drugs.
• uncorrected vision prevents subject from effectively viewing the stimuli, unless they can wear contact lenses during the recording session.
• inability to make normal eye movements (i.e.: saccades, smooth pursuit) required by study paradigms. Note: Deficit can be caused by taking medications that can potentially affect eye movements or any neurological condition that can interfere with making normal eye movement.
• psychological or psychiatric conditions that preclude sustained concentration or ability to perform the tasks.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stability of Fixation	During eye movement recording session (20 sec).	The ability to keep eye position fixed on a visual target, measured by the distance between the target and eye fixation point averaged over 20 sec.

Trial Locations

Locations (1)

Louis Stokes VA Medical Center, Cleveland, OH; 🇺🇸 Cleveland, Ohio, United States