Washington, District of Columbia 20422


Purpose:

Active duty military personnel serving in the current and recent conflicts in Afghanistan and Iraq are frequently exposed to blasts and other mechanisms of traumatic brain injury (TBI).1,2 Although physical trauma is not unexpected during war fighting, survival after blast-related head injury has become a common occurrence only in recent years. As such, the associated cerebral damage is less well studied and understood. The Brain Injury Outcomes (BIO) Study is a longitudinal study with the short-term objective of better characterizing multi-modal outcomes in individuals who have sustained a brain injury using a systems medicine approach. Long-term aims include monitoring participants for signs of emerging symptoms or age-related vulnerabilities. Identification of abnormality profiles for all severity levels of brain injury (from any source) reflects a second long-range goal. Third, the investigators will examine and compare physiology between Veterans who have sustained a Mild Traumatic Brain Injury (mTBI) with and without persisting symptoms and various co-morbidities including posttraumatic stress disorder (PTSD). A control group of Veterans who have not sustained a TBI will also be recruited for comparison. Fourth, the investigators intend to facilitate the clinical use of advanced methodologies, such as brain imaging and tissue measures, with the brain injured (and other populations). Finally, the investigators will assess methods of analysis, combination and integration for multi-modal data in search of diagnostic profiles. Increased knowledge of injury patterns and the trajectory associated with brain injury could contribute to better methods of diagnosis, monitoring and, perhaps, treatment. This investigation has spawned several sub-studies, one of which was the Validation of Brief Objective Neurobehavioral Detectors (BOND) of Mild TBI, which continues. The investigators are collaborating with Harvard/Boston Children's Hospital in the Angiogenic Signaling Signatures Identified in Stress and Trauma (ASSIST) sub-study. Oak Ridge National Laboratory (ORNL) is integrating BIO Study multi-modal data.


Study summary:

As of February 2016, 91 of the planned sample have been recruited and evaluated. Recruitment, enrollment, evaluation and re-evaluation is continuing.


Criteria:

Inclusion Criteria: 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 Criteria: 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


NCT ID:

NCT00724607


Primary Contact:

Principal Investigator
Julie C Chapman
Washington DC VA Medical Center, Washington, DC

Julie C Chapman
Phone: (202) 745-8000 ext. 6207
Email: julie.chapman@va.gov


Backup Contact:

N/A


Location Contact:

Washington, District of Columbia 20422
United States

Julie C Chapman
Phone: 202-745-8000
Email: julie.chapman@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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