The NIH and DoD have commissioned major translational research initiatives aimed at: 1) advancing the basic and clinical science of TBI and 2) fueling progress toward a precision medicine model for TBI. the Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study (TRACK-TBI NINDS#U01 NS086090; 2013-2019) marks the largest and most comprehensive precision natural history study of TBI ever conducted in the U.S. To date, TRACK-TBI has enrolled over 3,000 TBI patients across the injury spectrum from concussion to coma, along with separate orthopedic and friend control cohorts, at 18 U.S. Level 1 Trauma Centers.

TRACK-TBI’s extensive protocol empowers rich, multidimensional characterization of the clinical, neuroimaging, and blood-based biomarker features of TBI. Participants are followed longitudinally for one year from time of injury, using the NINDS TBI Common Data Elements (CDEs), which have been conformed to CDISC standards, as encouraged by the U.S. Food and Drug Administration (FDA) for use in IND and other applications. TRACK-TBI has amassed the world’s largest and most comprehensive serial collection of standardized TBI neuroimaging (CT and MRI), using structural, functional, and diffusion phantoms for quantitative imaging and developed automated pipelines for imaging quality assurance.

TBI patients across the age (0-100y) and injury spectrum from concussion to coma, along with separate orthopedic and friend control cohorts, at 18 U.S. Level 1 Trauma Centers. TRACK-TBI’s extensive protocol empowers rich, multidimensional characterization of the clinical, neuroimaging, and blood-based biomarker features of TBI. Participants are followed longitudinally for one year from time of injury, using the NINDS TBI Common Data Elements (CDEs), which have been conformed to CDISC standards, as encouraged by the U.S. Food and Drug Administration (FDA) for use in IND and other applications. TRACK-TBI has amassed the world’s largest and most comprehensive serial collection of standardized TBI neuroimaging (CT and MRI), using structural, functional, and diffusion phantoms for quantitative imaging and developed automated pipelines for imaging quality assurance.

Leveraging TRACK-TBI and TED infrastructure and experience, TRACK-TBI NET will establish an innovative Phase 2 TBI adaptive clinical trials network that delivers on DoD and NIH recommendations.