Brain Injury Outcomes (BIO) Study
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 from 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 our 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, we will examine and compare physiology between veterans who have sustained a 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, we intend to facilitate the clinical use of advanced methodologies, such as brain imaging and tissue measures, with the brain injured (and other populations). Finally, we 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. We 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.
Posttraumatic Stress Disorder
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Validation of Brief Objective Neurobehavioral Detectors of Mild TBI|
- Modality: Neuroimaging; Primary Outcome Measures: FA, MD, AD, RD [ Time Frame: Every two years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Tissue samples are requested for 1.) current laboratory measures, 2.) current genomic, immunologic, angiogenic and endocrine measures, and 3.) future unknown measures.
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||June 2019 (Final data collection date for primary outcome measure)|
Validation study of screening instrument.
As of September 2015, 91 of the planned sample have been recruited and evaluated. Recruitment, enrollment, evaluation and re-evaluation is continuing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724607
|Contact: Julie C Chapman||(202) 745-8000 ext firstname.lastname@example.org|
|United States, District of Columbia|
|Washington DC VA Medical Center, Washington, DC||Recruiting|
|Washington, District of Columbia, United States, 20422|
|Contact: Julie C Chapman 202-745-8000 ext 6207 email@example.com|
|Principal Investigator: Julie C Chapman|
|Principal Investigator:||Julie C Chapman||Washington DC VA Medical Center, Washington, DC|