NOT-NS-19-027: Notice of Intent to Publish a Funding Opportunity Announcement for Biological Measures for Prognosing and Monitoring of Persistent Concussive Symptoms in Early and Middle Adolescents: Center Without Walls (CWOW) (U54 Clinical Trial Optional)

Notice of Intent to Publish a Funding Opportunity Announcement for Biological Measures for Prognosing and Monitoring of Persistent Concussive Symptoms in Early and Middle Adolescents: Center Without Walls (CWOW) (U54 Clinical Trial Optional)

Notice Number: NOT-NS-19-027

Key Dates

Release Date:January 07, 2019
Estimated Publication Date of Funding Opportunity Announcement: February 10, 2019
First Estimated Application Due Date: April 12, 2019
Earliest Estimated Award Date: October 01, 2019
Earliest Estimated Start Date: October 01, 2019

Related Announcements
None

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research on discovering validating biological measures to be used for assessing, prognosing, and monitoring recovery of adolescents who either clinically present with or are at risk for developing prolonged/persistent concussive symptoms following exposure to repetitive head impacts and/or concussion. 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 appropriate projects.

The FOA is expected to be published in Winter 2019 with an expected application due date in Spring 2019.

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 new FOA.

In addition, collaborative investigations combining expertise in pediatrics, rehabilitation, biomarker development, proteomics, neuroimaging, risk assessment, clinical outcomes research will be encouraged, and these investigators should also begin considering applying for this application.

The FOA will utilize the U54 Cooperative Agreement Center Without Walls (CWOW) mechanism that will included a 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. Applications' analysis plans are also expected to include potential mediating factors such as medication and the type and amount of post-injury treatment and rehabilitation provided to participants.

The U54 should include the following:(1) an 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 Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics platform and be able to coordinate with the NINDS biomarker repository BioSEND; (3) a least three research projects that will be used to address a list of research areas of interest.

Scientific projects will be expected to include both a (1) discovery / internal validation, and (2) an external validation stage to their project. In the discovery stage, each research project should focus on discovery of biological measures of persistent concussive symptoms. Where feasible, each project's biological measures should be collected across all research projects sites. During the internal validation stage, projects will be expected to determine the selectivity and sensitivity of a unique individual or set of biological measures for assessing, prognosing, and / or monitoring persistent concussive symptoms in an EMA population. For external validation, each of the research projects should collect the full set of biological measures to be validated 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 or monitoring recovery of persistent concussive symptoms in an EMA population should be developed.

It is expected that the FOA 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 FOA 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 theNINDS CDE Project.

This FOA may 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 may 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 may also expect that all biological specimens will be banked at the NINDS BioSEND Biomarkers Repository. Note that costs for collection are 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 (seeNOT-NS-15-046) and should be budgeted for in the application.

Funding Information

Estimated Total Funding $2,000,000 in direct costs
Expected Number of Awards The NINDS intends to fund up to 1 award.
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.853

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)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Indian/Native American Tribal Government (Federally Recognized)

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Patrick S. Frost Bellgowan, Ph.D.

National Institute of Neurological Disorders and Stroke (NINDS)

301-496-1447

psfb@mail.nih.gov