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Clinical Trials/NCT00875589
NCT00875589
Completed
Not Applicable

Eye-movement Recordings in the Diagnosis of Traumatic Brain Injury

VA Office of Research and Development1 site in 1 country26 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
VA Office of Research and Development
Enrollment
26
Locations
1
Primary Endpoint
Stability of Fixation
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
June 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Stability of Fixation

Time Frame: During eye movement recording session (20 sec).

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.

Study Sites (1)

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