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
  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:


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: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Holly B 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 B Henry    216-791-3800 ext 4657    holly.henry@va.gov   
Principal Investigator: Jonathan Jacobs, PhD         
Sponsors and Collaborators
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: June 2, 2014
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 October 19, 2014