Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Eye-movement Recordings in the Diagnosis of Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875589
• Other study ID #: B6403-R
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2009
• Last updated: October 15, 2015
• Start date: April 2011
• Est. completion date: June 2014

Study information

• Verified date: October 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stability of Fixation	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.	During eye movement recording session (20 sec).	No