Notice Number: NOT-NS-20-014
Key DatesRelease Date: October 10, 2019
National Institute of Neurological Disorders and Stroke (NINDS)
This Notice is to inform the research community that The National Institute of Neurological Disorders and Stroke (NINDS) intends to reissue the Funding Opportunity Announcement (FOA) RFA-NS-19-022 "Biological Measures for Prognosing and Monitoring of Persistent Concussive Symptoms in Early and Middle Adolescents: Center Without Walls (PCS-EMA CWOW)." When reissued, this FOA will continue to utilize the U54 grant mechanism. The research priorities will remain the same but will include some points of clarification. Modifications to this FOA will include the addition of research cores and a reduction in the number of required research projects from three projects to a single research project.
Like the initial FOA, the reissued FOA will solicit applications for research on discovering and performing an initial clinical validation of biological measures to be used for prognosing and monitoring recovery of adolescents who either clinically present with or are at risk for developing prolonged/persistent concussive symptoms following exposure to concussion and/or repetitive head impacts. These biological measures should then be incorporated into risk stratification algorithms to inform clinical care and patient stratification for future clinical trials. A key component of this FOA will be the broad sharing of clinical, neuroimaging, physiological, and biospecimen data to further advance research in the area of persistent concussive symptoms in early and middle adolescent (EMA; ages 11-17 years old) populations.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and an appropriate project design.
The FOA is expected to be published in Winter 2019 with an expected application due date in Spring 2020.
This FOA will utilize the NIH Specialized Center Cooperative Agreement (U54) activity code. Details of the planned FOA are provided below.
Research Initiative Details
This Notice encourages investigators with expertise and insights into this area of Traumatic Brain Injury (TBI) to begin to consider applying for this reissued FOA. In addition, collaborative investigative teams combining expertise in pediatrics, rehabilitation, biomarker development, proteomics, neuroimaging, risk assessment, and / or clinical outcomes research will be encouraged, and these investigators should also begin considering applying for this FOA.
The U54 Center Without Walls (CWOW) cooperative agreement mechanism employed by this FOA will support multi-site, multidisciplinary, research teams that work synergistically to discover, characterize, and validate a combination of biological measures for prognosis and/or monitoring recovery of persistent concussive symptoms with enrollment from multiple points of care (e.g., Emergency Departments, urgent care clinics, primary care, concussion/sports medicine clinics, or other specialty clinics) and participants with a variety of injury mechanisms (e.g., falls, sports, abusive head trauma, automobile accidents). Biological measures that are responsive may include, but are not limited to, neuroimaging, electroencephalography, oculomotor control, vestibular function, measures of auditory processing and speech production, autonomic responses, metabolomics, proteomics and other biofluid-based assays. Analysis plans should include potential mediating factors such as medication and the type and amount of post-injury treatment and rehabilitation provided to participants.
Components of the U54 are expected to include the following:(1) Administrative Core for management of reporting, establishing milestones, organizing communications among sites, and resolving disputes; (2) a Data Coordinating Core that will be responsible for data curation, quality, and submission to the FITBIR informatics platform and be able to coordinate with the NINDS biomarker repository BioSEND; (3) Research Cores that will be responsible for maintaining data acquisition standard operating procedures and specialized data analytics; (4) a single research project that will be used to address a list of research areas of interest; and (5) and overall component that describes the overall structure, function, and goals of the CWOW.
The scientific project will be expected to include both a (1) discovery / internal validation and a (2) cross-site clinical validation stage. The discovery stage should focus on discovery of biological measures of persistent concussive symptoms. During the internal validation stage, the project will be expected to determine the selectivity and sensitivity of a unique individual or set of biological measures for prognosing and / or monitoring persistent concussive symptoms in an EMA population across a variety of injury mechanisms. For the cross-site clinical validation stage, the biological markers that have been internally validated should be collected, from a new cohort of participants, to determine the selectivity and sensitivity of these measures across multiple sites and in multiple clinical contexts. Following validation, a risk stratification algorithm for prognosing and/or monitoring recovery of persistent concussive symptoms in an EMA population should be developed.
It is expected that the RFA will require the incorporation of the NINDS Core TBI pediatric common data elements (CDEs) and appropriate Core CDEs in the NINDS Sports Concussion CDE set. Additionally, the RFA is expected to require the use of the NINDS CDEs for both outcome and non-outcome measures (including, but not limited to demographics, medical and injury history, history of abusive injury, family history, medications, neuroimaging, rehabilitation strategy, and standardized outcome assessments) as described by the NINDS CDE Project.
This FOA will require a data sharing schedule that is consistent with NINDS's TBI data submission policy NOT-NS-17-029. Further, to ensure maximal value of the project, the data sharing plan will require sharing of a "limited" clinical data set (e.g., clinical assessment & outcome measures, symptom lists, mechanism of injury, demographics, etc.) to be available in FITBIR in a limited access "public” state no more than 1-year after collection.The FOA will expect that all biological specimens be banked at the NINDS BioSEND Biomarkers Repository. Note that costs for collection is NOT included as a component of the NINDS BioSEND Biomarkers Repository award. Therefore, most costs for the biospecimen banking are borne by the grantees utilizing this resource (see NOT-NS-15-046) and should be budgeted for in the application.
Estimated Total Funding NINDS intends to commit $2,000,000 direct costs per year
Expected Number of Awards NINDS intends to fund up to 1 award
Estimated Award Ceiling $2,000,000 direct costs per year.
Primary CFDA Numbers TBD
Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
For-Profit Organization (Other than Small Business)
Please direct all inquiries to:
Patrick S. Frost Bellgowan, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)