Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00875589
First received: April 1, 2009
Last updated: October 15, 2015
Last verified: October 2015

April 1, 2009
October 15, 2015
April 2011
December 2013   (final data collection date for primary outcome measure)
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.
Improved reading performance [ Time Frame: Three years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00875589 on ClinicalTrials.gov Archive Site
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Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury
Eye-movement Recordings in the Diagnosis of Traumatic Brain Injury
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.
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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Adult betwenn 18 and 55 years old with and without a diagnosis of MTBI
Traumatic Brain Injury
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  • Control
    Control subjects with no Mild Traumatic Brain Injury (MTBI) and no Post-Traumatic Stress Disorder (PTSD)
  • MTBI
    Subject with a diagnosis for Mild Traumatic Brain Injury (MTBI)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00875589
B6403-R
No
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VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Jonathan Jacobs, PhD Louis Stokes VA Medical Center, Cleveland, OH
VA Office of Research and Development
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP