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Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: April 1, 2009
Last updated: October 15, 2015
Last verified: October 2015
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.

Condition Phase
Traumatic Brain Injury
Phase 1

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Eye-movement Recordings in the Diagnosis of Traumatic Brain Injury

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Stability of Fixation [ Time Frame: During eye movement recording session (20 sec). ] [ Designated as safety issue: No ]
    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.

Enrollment: 26
Study Start Date: April 2011
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Control subjects with no Mild Traumatic Brain Injury (MTBI) and no Post-Traumatic Stress Disorder (PTSD)
Subject with a diagnosis for Mild Traumatic Brain Injury (MTBI)

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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult betwenn 18 and 55 years old with and without a diagnosis of MTBI

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00875589

United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Jonathan Jacobs, PhD Louis Stokes VA Medical Center, Cleveland, OH
  More Information

Responsible Party: VA Office of Research and Development Identifier: NCT00875589     History of Changes
Other Study ID Numbers: B6403-R 
Study First Received: April 1, 2009
Results First Received: September 10, 2015
Last Updated: October 15, 2015
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Traumatic Brain Injury
Eye movement recording

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System processed this record on October 27, 2016