To achieve TED’s central goal of creating a widely interrogatable Metadataset, we have leveraged national, multi-institutional and multidisciplinary consortia with established infrastructure and clinical research networks. The NINDS-funded TRACK-TBI Consortium (Transforming Research and Clinical Knowledge in TBI, U01 NS086090), TRACK’s Pilot study, and the Concussion Research Consortium (CRC), a clinical data repository with extensive preinjury baseline and longitudinal post injury assessment data on over 1,200 athletes with sport-related concussion (SRC) and several hundred matched control athletes, form the initial core databases of the TED Metadataset.
Willing contributors internationally have since added their legacy data: TBIcare is a European Union based study that enrolled over 200 adults with TBI over a wide range of severity, collecting clinical data as well as imaging studies and biospecimens. ProTECT III was an interventional study with a cohort of nearly 1000 adults who experienced a moderate to severe head injury caused by blunt trauma, e.g., a car accident or a fall. The Investigators sought to determine if progesterone, a hormone normally found in our bodies, was able to limit the amount of brain damage from TBI. The Metadataset also contains imaging and clinical outcomes data from the Macrostructural and Microstructural Imaging Biomarkers of Traumatic Brain Injury. This observational study enrolled approximately 250 patients including over 100 healthy controls, and collected structural MRIs and DTIs at 1, 6, and 12 months post injury. Currently rounding out the Metadataset is data from the COBRIT study, which recruited over 1000 patients. Patients were administered citicoline or a placebo with functional outcome assessments taken at 30, 90, and 180 days after randomization. As the TED Initiative progresses, more datasets will be incorporated into the Metadataset.
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TRACK-TBI is building a large database that integrates clinical, imaging, proteomic, genomic, and outcome biomarkers starting within 24 hours of injury and continuing to 1-year post injury. The goals of TRACK-TBI are to establish more precise methods for TBI diagnosis and prognosis, refine outcome assessment, and compare the effectiveness and costs of TBI care. In its pilot phase, TRACK-TBI validated the feasibility of the TBI Common Data Elements (TBI-CDEs) and collected detailed clinical data on 650 subjects across the injury spectrum, along with CT/MRI imaging, blood biospecimens, and detailed outcomes. It also established an infrastructure of integrated databases, imaging repositories, biosample repositories, and multicenter expertise. The TRACK-TBI Pilot dataset was the first to populate the Federal Interagency Traumatic Brain Injury Research (FITBIR) repository. Among the early products of TRACK-TBI Pilot are multicenter evaluations of imaging and proteomic biomarkers. This work represents a significant step toward improved stratification of heterogeneous patient subgroups within the traditional TBI population. While this improves precision of outcome assessment beyond the GOS-E, critical gaps in the TBI-CDE outcome battery were identified with respect to more severely injured patients; therefore, investigators designed a flexible outcome assessment battery that will be examined in the recently funded TRACK-TBI study.
The Concussion Research Consortium (CRC) has spearheaded several large, multi-center studies on the effects of sport-related concussion (SRC) over the past 20 years. CRC-led efforts funded by federal, industry, and private research partners have enrolled over 25,000 youth, high school, collegiate, and professional athletes in studies investigating both acute and chronic effects of SRC. CRC cohorts are extremely well characterized by a broad array of clinical measures (symptom inventories, cognitive and balance testing; electrophysiological and neuroimaging studies in subsets). CRC-led research initiatives have had major translational impact on the development of consensus guidelines for the assessment and management of SRC. Three current CRC investigations directly support the TED aims. A DoD-funded study is focused on a neurobiopsychosocial predictor and outcome models in acute SRC, and the GE-NFL Head Health Challenge project looks at advanced MRI diagnostic and prognostic biomarkers in SRC. The NCAA 15 Year Study looks at long-term neurological health outcomes in former college athletes with and without SRC who were studied prospectively in the original NCAA Concussion Study 15 years ago. In addition, the Center for Study of Retired Athletes at the University of North Carolina is conducting systematic long-term outcome studies in former NFL players and other professional athletes. All CRC studies now employ an extensive array of clinical measures and biomarkers.