Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury

This study is not yet open for participant recruitment.

Verified by Department of Veterans Affairs, April 2009

First Received: April 1, 2009 Last Updated: April 2, 2009 History of Changes

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00875589

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
Traumatic Brain Injury	Other: Eye movement recording and analysis

MedlinePlus related topics: Traumatic Brain Injury

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Eye-Movement Recordings in the Diagnosis of Traumatic Brain Injury

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:	30
Study Start Date:	January 2010
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Screening for Inclusion - Neuopsych evaluation for Mild Traumatic Brain Injury (MTBI) with no Post-Traumatic Stress Disorder (PTSD)
2: Experimental 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.
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 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

OIF/OEF Veteran;
Neuropsych diagnosis of MTBI without PTSD

Exclusion Criteria:

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
Cleveland, Ohio, United States, 44106

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 ( Jacobs, Jonathan - Principal Investigator )
Study ID Numbers:	B6403R
Study First Received:	April 1, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00875589 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Traumatic Brain Injury
Eye movement recording

Study placed in the following topic categories:

Craniocerebral Trauma
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Craniocerebral Trauma
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries

ClinicalTrials.gov processed this record on May 07, 2009