The purpose of this FOA is to support the development and validation of pathophysiologically based preclinical outcome measures or functional markers that align closely with practical clinical assessments in spinal cord injury (SCI) and/or traumatic brain injury (TBI). Bedside knowledge and experience will be leveraged to create better assessment tools for preclinical studies, and the resulting data will be made available to researchers. The goal is to improve the value of preclinical studies to inform clinical diagnoses and prognoses and therapeutic translation.
Funds from the NINDS will be made available through the UG3/UH3 phased cooperative agreement award mechanism. The UG3 phase will allow investigators to develop and internally validate a multidisciplinary battery of outcome measures or functional markers that distinguishes between types of injury induced pathology in SCI and/or TBI and then track the longitudinal progression of the response to injury in existing models. During the UG3 phase, a TOP-NT Consortium will be formed to facilitate collaboration across sites and to establish data collection and sharing strategies that will enable broad access to methodologies and representative datasets.
The UH3 phase will support extension and cross-validation studies for the preclinical assessments across models and sites, and will implement the data collection and data sharing mechanisms developed by the TOP-NT Consortium. A UG3 project that meets transition milestones will be administratively considered by NINDS and prioritized for transition to the UH3 award. Applicants responding to this FOA must address objectives for both the UG3 and UH3 phases and propose appropriate transition milestones.