Clinical Research is also supported by our core facilities. Each core has a team of highly skilled staff and state-of-the-art equipment that are utilized for core-driven, CNRM-funded, and collaborative research initiatives. See below for information about each of our clinical cores.
Our Biomarkers Core processes, receives, catalogs, analyzes, and stores biosamples (primarily blood) from studies that collaborate with our Biospecimen Repository. The Biomarkers Core works with studies that investigate military personnel and civilians with traumatic brain injuries (TBIs) and comparable controls. In addition to processing and storing study biosamples, our Core can also provide advanced analysis methods to evaluate:
- Epigenetic modifications
- mRNA, circular and noncoding RNA expression
- High sensitivity protein assays for various proteins- including tau, neurofilament light, and glial fibrillary acidic protein
In June 2020, our Biospecimen Repository moved to a new location that was uniquely designed to meet the growing needs of the Biomarkers Core. The Repository currently holds approximately 111,000 specimens but has the capability of holding over 200,000.
Plans are underway to add onsite analytical capabilities to the Biorepository in early 2021, which will enable efficient facilitation of hypothesis-driven research. This will include the installation and maintenance of a Single Molecule Array (Simoa, Quanterix) within the Repository. This exciting onsite capability will allow for an ability of collaborators to utilize this method for high sensitivity of brain-injury related proteins.
Interested in working with Biomarkers Core and Biospecimen Repository? Please send inquiries and questions to email@example.com.
Efforts from our Biomarkers Core and biosamples from our Biospecimen Repository have contributed to recent advances in exploring blood-based biomarkers of TBI. Several of these advances include:
Devoto, C., Lai, C., Qu, B., Guedes, V., Walker, W., Wilde, E., Diaz-Arrastia, R., Kenney, K., Gill, J., (2020). Exosomal MicroRNAs in Veterans with Mild Traumatic Brain Injury: Preliminary Results from a Chronic Effects of Neurotrauma Consortium (CENC) Biomarker Discovery Project. Journal of Neurotrauma, 94 (23) e2412-e2423; DOI: 10.1212/WNL.0000000000009577.
Pattinson CL, Meier TB, Guedes VA, Gill, J., et al. Plasma Biomarker Concentrations Associated With Return to Sport Following Sport-Related Concussion in Collegiate Athletes—A Concussion Assessment, Research, and Education (CARE) Consortium Study. JAMA Network Open. 2020;3(8):e2013191. doi:10.1001/jamanetworkopen.2020.13191
Shahim, P., Politis, A., van der Merwe, A., Moore, B., Chou, Y. Y., Pham, D. L., Butman, J. A., Diaz-Arrastia, R., Gill, J. M., Brody, D. L., Zetterberg, H., Blennow, K., & Chan, L. (2020). Neurofilament Light as a Biomarker in Traumatic Brain Injury. Neurology, 10.1212/WNL.0000000000009983. Advance online publication. https://doi.org/10.1212/WNL.0000000000009983
Stone, J. R., Avants, B. B., Tustison, N., Wassermann, E., Gill, J., Polejaeva, E., Dell, K. C., Carr, W., Yarnell, A. M., LoPresti, M. L., Walker, P. B., O'Brien, M., Domeisen, N., Quick, A., Modica, C. M., Hughes, J. D., Haran, F. J., Goforth, C. W., & Ahlers, S. (2020). Functional and structural neuroimaging correlates of repetitive low-level blast exposure in career breachers. Journal of neurotrauma, 10.1089/neu.2020.7141. Advance online publication. https://doi.org/10.1089/neu.2020.7141
Our Informatics Core offers a variety of resources and data support services to our clinical trials, translational research, operational research initiatives, and collaborative studies. These resources and services accommodate all stages of a study’s life cycle and a broad range of data types.
The Informatics Core manages various platforms for data collection, capture, secure sharing, storage, and analytics. These platforms include:
- CNRM’s Collection, Access, Sharing, and Analytics Platform (CASA)
- CNRM’s Data Repository
- CNRM’s Electronic Case Report Form Library
- CNRM’s TBI Research Opportunities and Outreach for Participation in Research Studies (TROOPS)
The Core also provides a range of support services, offering studies assistance with:
- Data collection, retrieval, transfer, auditing, analysis, storage, and backup
- Software development and testing
- Quality assurance
- Case Report Form (CRF) and Electronic Case Report Form (E-CRF) creation/setup
- Global Unique Identifier (GUID) generation and management
- Completion of study regulatory documents, in particular data sharing agreements, specifically with the Defense Health Agency’s Data Sharing Agreement Application
- Statistical development and analysis, to include data modeling and machine learning
- Data management related to CNRM’s Data Repository and to the Federal Interagency Traumatic Brain Injury Research (FITBIR)
- Informatics consultation (e.g., identification of a project’s resources and needs)
- Computations resources and tools
- Custom mobile device app development
Our Informatics Core ensures each study participates in the TBI research community’s data standardization efforts. It requires projects to incorporate the National Institute of Neurological Disorders and Stroke’s TBI common data elements, unique data elements, and form structure. It also facilitates the submission of de-identified data to CNRM’s Data Repository and to the FITBIR informatics system.
Interested in working with our Informatics Core? Please send all inquiries and questions to CNRMInformatics@usuhs.edu.
Study recruitment is a consistent rate limiting factor across TBI and post-traumatic stress (PTS) research. We created the TBI Research Opportunities and Outreach for Participation in Studies (TROOPS) referral program to address this need.
TROOPS is a web-based referral program that can expedite and enhance the participant recruitment and referral process. Prospective study participants directly self-enroll via a web-based platform that is accessible from any computer, tablet, or smartphone. Referral program staff pre-screen enrollees for eligibility in participating studies and provide contacts to study teams. This process eases the burden of recruitment on study teams by providing a registry of willing study participants with a wide variety of relevant medical histories and military backgrounds.
If you are interested in using our TROOPS referral program for your study, please send an active study protocol and consent form to CNRMstudies@usuhs.edu. All studies are thoroughly vetted by CNRM leadership. Study teams will be asked to include a statement regarding TROOPS in the recruitment section of their protocol. Study teams will also be required to complete an impact statement. There is no cost associated with utilizing TROOPS referrals. Participating studies are largely focused on military cohorts but our TROOPS referral program is not limited to only military-based studies. TROOPS enrolls active duty service members, veterans, and civilians.