Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury
Eye-movement Recordings in the Diagnosis of Traumatic Brain Injury
1 other identifier
observational
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
October 8, 2015
CompletedNovember 11, 2015
October 1, 2015
2.7 years
April 1, 2009
September 10, 2015
October 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Study Arms (2)
Control
Control subjects with no Mild Traumatic Brain Injury (MTBI) and no Post-Traumatic Stress Disorder (PTSD)
MTBI
Subject with a diagnosis for Mild Traumatic Brain Injury (MTBI)
Eligibility Criteria
Adult betwenn 18 and 55 years old with and without a diagnosis of MTBI
You may qualify if:
- OIF/OEF Veteran;
- Neuropsych diagnosis of MTBI
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan Jacobs, PhD
- Organization
- Daroff-Dell'Osso Ocular Motility Laboratory
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Jacobs, PhD
Louis Stokes VA Medical Center, Cleveland, OH
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2009
First Posted
April 3, 2009
Study Start
April 1, 2011
Primary Completion
December 1, 2013
Study Completion
June 1, 2014
Last Updated
November 11, 2015
Results First Posted
October 8, 2015
Record last verified: 2015-10