Posted September 23, 2014
Dr. David Cifu, Dr. Ramon Diaz-Arrastia, Dr. Rick Williams; Chronic Effects of Neurotrauma Consortium
Dr. Alan Peterson and Dr. Terry Keane; Consortium to Alleviate PTSD
In 2012, the U.S. Department of Defense (DoD), Defense Health Program, and the Department of Veterans Affairs (VA) joined forces to make a significant impact on two of the most prominent health concerns affecting Service Members and Veterans: traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD). Requests for proposals were issued to establish major, jointly funded, multi-center consortia to address each of these military-relevant conditions in response to Presidential Executive Order 13625 and aligned with the National Research Action Plan. These efforts resulted in the creation of the Chronic Effects of Neurotrauma Consortium (CENC) and the Consortium to Alleviate PTSD (CAP). Each consortium began operations in September 2013, though their organization and infrastructure were conceptualized during the previous year as the consortia proposals were prepared. Both consortia aim to contribute significantly to the understanding and knowledge base of, and identify new treatments and clinical guidance to help those afflicted with, these conditions. Oversight of the consortia is carried out through government steering committees that draw from program leadership at the DoD, VA, National Institutes of Health, and other agencies with complementary research portfolios.
The CENC is a coordinated, multi-center collaboration linking basic science and translational and clinical neuroscience researchers from the VA, military, and academia to effectively address the diagnostic and therapeutic challenges relating to long-lasting effects of TBI. The CENC is led by Dr. David Cifu at Virginia Commonwealth University and includes 18 participating institutions, all of which have spent the past year building an extensive administrative and scientific infrastructure for consortium operations through a coordinating center and leadership working group of PIs. The consortium leverages an extensive nationwide network of established researchers with preclinical and clinical expertise conducting research ranging from mechanistic studies to multi-site clinical studies. It features integrated research cores including a biorepository of clinical samples that can become a valuable resource for the research community. The CENC has established operating processes and started work on a number of research studies.
The CENC team has found ways to implement knowledge, data, and clinical research populations from previously funded DoD and VA efforts to enhance current and future studies and has initiated a process to bring in new research projects and collaborators. This effort has resulted in a variety of integrated projects that represent the beginning of a CENC research portfolio. The CENC is nearing initiation of a flagship longitudinal observational study of the chronic effects of neurotrauma that will monitor hundreds of Service Members and collect valuable data to inform TBI treatments for years to come. Subsequent studies will "fill in" a road map for progress designed to understand the linkage between blast exposures with TBI, its chronic effects, and neurodegeneration. CENC lead study investigators are working closely with investigators from the Defense and Veterans Brain Injury Center to find ways to maximize research findings from complementary efforts. All consortium studies utilize integrated research cores such as repositories for clinical samples, study data, and neuroimaging files. The consortium is collecting data aligned to common data elements and coded (aka de-identified) data will be submitted to the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system in an effort to facilitate data sharing among the research community.
The CAP will improve the psychological and physical health and well-being of Service Members and Veterans who have deployed in support of Operations Enduring Freedom (OEF), Iraqi Freedom (OIF), and New Dawn (OND) by developing and evaluating the most effective diagnostic, prognostic, preventive, treatment, and rehabilitative strategies for combat-related PTSD and comorbid conditions. The consortium is headquartered at the University of Texas Health Science Center at San Antonio (UTHSCSA), where the PI, Dr. Alan Peterson, has the opportunity to leverage his substantial expertise from leading the successful consortium known as the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) also based at the same institution. The CAP infrastructure utilizes a specialized group of cores to support consortium research projects. Cores include the Coordinating Center at UTHSCSA and the National Center for PTSD/VA Boston Healthcare System for administration of the overall effort, an Assessment Core to coordinate the use of common data elements across all consortium studies, a Biomarker and Genomics Core, and a Neuroimaging Core. A Data and Biostatistics Core will coordinate data capture, storage, and analysis for consortium studies as well as integrate the information across the spectrum of federal data repositories. Regular communication to maintain progress on multiple fronts has been a hallmark of the CAP project team.
In its first year of operation, the CAP has reached out to investigators across the psychological health research community to form collaborations for potential consortium projects. Hundreds responded to a broadly disseminated RFA released in June 2014 that solicited preproposals for two separate rounds of submissions. After a rigorous review process, applicants were selected to submit full proposals to be reviewed by the VA-DoD peer review system. Subsequently, studies will be selected for implementation with approval by a Government Steering Committee. A randomized clinical trial of cognitive behavioral therapy for posttraumatic headache will initiate the CAP research portfolio and will recruit recent military Veterans at the South Texas Veterans Healthcare System Polytrauma Rehabilitation Center and Polytrauma System of Care. The study may expand to nearby military bases, where active duty Service Members could be included. A slate of high-quality studies is currently under review by the Government Steering Committee for implementation at both VA and DoD sites in support of the consortium's mission to serve military Service Members and Veterans. Additional studies will be added as gaps in the CAP PTSD portfolio are identified. Biomarker and neuroimaging assessments will be integrated into CAP studies whenever possible to determine if they can be used to confirm the diagnosis of PTSD, inform the course of treatment, enhance psychological resiliency, or prevent the onset of chronic PTSD and related conditions.
These two DoD/VA-sponsored consortia are poised to identify and confirm clinically relevant diagnostic and prognostic biomarkers and investigate effective evidence-based treatments for combat-related TBI, PTSD, and associated co-morbidities. Furthermore, these consortia will contribute invaluable clinical information and samples to support ongoing research efforts in the military, Veteran, and academic research communities for years to come. The men and women who have deployed in support of our nation deserve nothing less.