Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00875589
First received: April 1, 2009
Last updated: June 2, 2014
Last verified: May 2014

April 1, 2009
June 2, 2014
April 2011
December 2014   (final data collection date for primary outcome measure)
Improved reading performance [ Time Frame: Three years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00875589 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Traumatic Brain Injury
Other: Eye movement recording and analysis
Participant will have their eye movements recorded while watching a series of moving and static lights.
  • No Intervention: Arm 1
    Screening for Inclusion - Neuropsych evaluation for Mild Traumatic Brain Injury (MTBI) with no Post-Traumatic Stress Disorder (PTSD)
  • Experimental: Arm 2
    Diagnose for MTBI - patient eye movement is tracked while looking at lights
    Intervention: Other: Eye movement recording and analysis
  • Arm 3
    Intervention - Eye movement training to improve reading performance
    Intervention: Other: Eye movement recording and analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2015
December 2014   (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: Holly B Henry (216) 791-3800 ext 4657 holly.henry@va.gov
United States
 
NCT00875589
B6403-R
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Jonathan Jacobs, PhD VA Medical Center, Cleveland
Department of Veterans Affairs
May 2014

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