Brain Injury Outcomes (BIO) Study (BIO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00724607|
Recruitment Status : Recruiting
First Posted : July 29, 2008
Last Update Posted : November 7, 2017
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.
|Condition or disease|
|Brain Concussion Posttraumatic Stress Disorder|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Validation of Brief Objective Neurobehavioral Detectors of Mild TBI|
|Actual Study Start Date :||May 6, 2008|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
TBI (Case) Group
Members of the TBI group have sustained a TBI in accordance with inclusion/exclusion criteria. However, the investigative staff administering, scoring, analyzing and interpreting the data will be blinded to the group status of the participant.
Non-TBI (Control) Group
Members of the Non-TBI group have not sustained a TBI and are in accordance with other provisions of the inclusion/exclusion criteria. However, the investigative staff administering, scoring, analyzing and interpreting the data will be blinded to the group status of the participant. This longitudinal study will utilize a control group to account for normal aging and other control factors.
Non-TBI Non-deployed (Control) Group
Members of the Non-TBI Non-Deployed group have neither sustained a TBI nor have been deployed but are in accordance with other provisions of the inclusion/exclusion criteria. However, the investigative staff administering, scoring, analyzing and interpreting the data will be blinded to the group status of the participant. This longitudinal study will utilize this Non-deployed control group to account for deployment-specific factors.
- Fractional anisotropy (FA) [ Time Frame: Every two years ]In this longitudinal study with multiple measurement modalities (i.e., neuroimaging, biospecimens, cognition, etc.), the primary outcome measures are from the neuroimaging modality, specifically, the diffusion tensor imaging (DTI) sequences. FA is one of the quantitative metrics yielded by the DTI sequence. FA is a ratio of the directional flows of water molecules within axonal bundles and is interpreted as a representation of the overall structural health of the bundle.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|