The Chronic Effects of Neurotrauma Consortium (CENC) multi-centre observational study: Description of study and characteristics of early participants

Abstract

Primary objectives: To establish and comprehensively evaluate a large cohort of US veterans who served in recent military conflicts in order to better understand possible chronic and late-life effects of mild traumatic brain injury (mTBI), including those that may stem from neurodegeneration.

Research design: Cross-sectional and prospective longitudinal.

Methods and procedures: Inclusion criteria are prior combat exposure and deployment(s) in Operation Enduring Freedom, Operation Iraqi Freedom or one of their follow-on conflicts (collectively OEF/OIF). Effects of mTBI will be assessed by enrolling participants across the entire spectrum of mTBI, from entirely negative to many mTBIs. Longitudinal assessments consist of in-person comprehensive testing at least every 5 years, with interval annual telephonic testing. The primary outcome is the composite score on the NIH Toolbox neuropsychological test battery. Assessments also include structured interviews, questionnaires, traditional neuropsychological testing, motor, sensory and vestibular functions, neuroimaging, electrophysiology, genotypes and biomarkers.

Main outcomes and results: The authors fully describe the study methods and measures and report demographic and exposure characteristics from the early portion of the cohort of OEF/OIF veterans.

Conclusions: This centrepiece observational study of the Chronic Effects of Neurotrauma Consortium (CENC) is successfully launched and, within several years, should provide fertile data to begin investigating its aims.

Keywords:

• Concussion
• traumatic brain injury
• military
• veterans
• post-concussion syndrome
• cohort studies

Acknowledgements

The CENC Observational Study Site PIs or co-PIs also include: Blessen Eapen, MD (SanAntonio), Carlos Jaramillo, MD (SanAntonio), Ajit Pai, MD (Richmond), Maulik Purohit, MD (Fort Belvoir), and Randall Scheibel, PhD (Houston). We also acknowledge the efforts of the entire CENC Observational Study Leadership Working Group and Core Team members who also include: Justin Alicea, Ramon Diaz-Arrastia (Consortium Co-PI), Jessica Berumen, Katrina Burson, Margaret Clarke, Doreen Collins, Shannon Cusack, Cheryl Ford-Smith, George Gitchel, Harvey Levin, Henry Lew, Daryl Matthews, Scott McDonald, Tamara McKenzie-Hartman, Nicholas Pastorek, Judy Pulliam, Risa Richardson, Robert Shin, James K. Sickinger, Chris Siege, Nancy Temkin, Doug Theriaque, Maya Troyanskaya, Rodney Vanderploeg, and Elizabeth Wilde. This material is based upon work supported with resources and the use of facilities at: Hunter Holmes McGuire Veterans Affairs Medical Center (VAMC) in Richmond, VA; James A. Haley Veterans Hospital (VH), Tampa, FL; Michael E. DeBakey VAMC, Houston, TX; Audie L. Murphy Memorial VH, San Antonio, TX; and is based upon work supported in part by the Defense and Veterans Brain Injury Center, US Army Medical Research and Material Command (USAMRMC).

Declaration of interest

This work was supported by grant funding from: Department of Defense, Chronic Effects of Neurotrauma Consortium (CENC) Award W81XWH-13-2-0095 and Department of Veterans Affairs CENC Award I01 CX001135. The authors report no conflicts of interest. The views, opinions and/or findings contained in this article are those of the authors and should not be construed as an official Veterans Affairs or Department of Defense position, policy or decision, unless so designated by other official documentation.