Long Term Clinical Correlates of TBI: Imaging, Biomarkers, Clinical Phenotyping

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Abstract

This study received CNS IRB Blue approval on March 17, 2010. The study team is fully staffed and we are actively recruiting patients for this protocol. In July 2011 we received IRB approval for a sub study that broadens the study inclusion criteria up to 5 years since injury. The sub-study will focus on collecting primarily the TBI Common Data Elements (CDEs), bloods, and imagining. In June 2012 the IRB approved expanding our enrollment age range from 18-70, to 18 and older. This same amendment exchanged PET-CT for PET-MRI in the imaging section of the protocol. A section regarding offered treatment was added to address the needs of those subjects who have functional needs with limited access to community resources. To date, this study has enrolled 127 patients, 74 of which are enrolled in the prospective cohort study and followed longitudinally. Previous recruitment challenges have been addressed with the expansion of a formulized recruitment effort and the opening of communication between the Recruitment Core and the Acute TBI Protocol under Dr. Larry Latour. Our research team has also been engaged in outreach to the community via support groups, and has initiated discussions around more formal collaborations with other TBI experts in the area, including new trauma teams in the area, such as George Washington University