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Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury

This study is currently recruiting participants.
Verified January 2013 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: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Traumatic Brain Injury
 Other: Eye movement recording and analysis
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Eye-movement Recordings in the Diagnosis of Traumatic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Improved reading performance [ Time Frame: Three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Other: Eye movement recording and analysis
Participant will have their eye movements recorded while watching a series of moving and static lights.
Arm 3
Intervention - Eye movement training to improve reading performance
 Other: Eye movement recording and analysis
Participant will have their eye movements recorded while watching a series of moving and static lights.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875589

Contacts
Contact: Holly Henry (216) 791-3800 ext 4657 holly.henry@va.gov

Locations
United States, Ohio
VA Medical Center, Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Holly Henry     216-791-3800 ext 4657     holly.henry@va.gov    
Principal Investigator: Jonathan Jacobs, PhD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Jonathan Jacobs, PhD VA Medical Center, Cleveland
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00875589     History of Changes
Other Study ID Numbers: B6403-R
Study First Received: April 1, 2009
Last Updated: January 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Traumatic Brain Injury
Eye movement recording

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013