Status:
COMPLETED
Brain Injury Outcomes (BIO) Study
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Oak Ridge National Laboratory
Johns Hopkins University
Conditions:
Brain Concussion
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-59 years
Brief Summary
Many active duty military, national guard, and reserves personnel who served in the recent conflicts in Afghanistan and Iraq were exposed to blasts and other mechanisms of traumatic brain injury (TBI)...
Detailed Description
This study was previously paused due to the pandemic. Many active duty military, national guard, and reserves personnel who served in the recent conflicts in Afghanistan and Iraq were exposed to blas...
Eligibility Criteria
Inclusion
- Inclusion criteria for TBI Group (Case Group):
- TBI group Veterans must:
- be enrolled at the Washington, DC VA Medical Center
- be an Operation Enduring Freedom (OEF)/ Operation Iraqi Freedom (OIF)/OND Veteran
- be between the ages of 18 and 59, inclusive
- have at least 10 years of education
- be able to fit into scanner (i.e., weigh less than 400 pounds)
- have a brain injury (based upon VHA criteria)
- be at least one year post-injury
- Inclusion criteria for NonTBI Group (Control Group):
- NonTBI group Veterans must:
- be enrolled at the Washington, DC VAMC
- have been active duty (whether deployed or not) during OEF and/or OIF and/or OND
- be between the ages of 18 and 59, inclusive
- have at least 10 years of education
Exclusion
- Exclusion Criteria for both the Case and Control Groups:
- Veterans must NOT:
- be colorblind or have any visual impairment that interferes with reading or writing
- have any upper extremity dysfunction that prevents the use of a pencil or computer mouse or keyboard
- meet criteria for substance dependence within 1 month of the evaluation
- have a current acute or unstable psychiatric condition
- have a current diagnosis (or symptoms consistent with) schizophrenic or bipolar disorders, or severe uni-polar depression
- be in significant pain during the evaluation (patient subjective report)
- have a diagnosis of diabetes (PET imaging considerations)
- have had or currently have any other injury, medical or neurological illness, or exposure that could potentially explain cognitive deficits (e.g., Central Nervous System disease, prior brain injury, seizure disorder, or HIV)
- be taking prescription drugs that significantly interfere with outcome measures
- have any devices or material implanted, embedded, or attached to the body containing ferrous material that interferes with MR imaging (i.e., pacemaker, shrapnel)
- Be a pregnant or lactating female (MRI considerations)
- Display behavior that would significantly interfere with validity of data collection or safety during study
Key Trial Info
Start Date :
May 6 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 15 2024
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00724607
Start Date
May 6 2008
End Date
January 15 2024
Last Update
June 18 2024
Active Locations (1)
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1
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, United States, 20422-0001