Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institute of Neurological Disorders and Stroke (NINDS)
The purpose of this notice is to inform potential applicants of a change to the Research Objectives and Research Strategy for RFA-NS-20-016 "Biological Measures for Prognosing and Monitoring of Persistent Concussive Symptoms in Early and Middle Adolescents: Center Without Walls (PCS-EMA CWOW) (U54 Clinical Trial Not Allowed)." This change will be effective for the June 26, 2020 receipt date. Changes are shown in bold italics below.
Currently Reads:
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Specific Research Objectives
This FOA solicits multicenter applications from multidisciplinary groups in order to develop, and then perform an initial clinical validation of objective biological measures to improve accuracy for prognosticating and / or monitoring persistent concussive symptoms that result from concussion and/or repetitive head impacts in adolescent populations. The overarching goal of this program is to develop and validate biological measures that will improve prognosis of persistent concussive symptoms in EMA patients that accounts for and is sensitive to individual variability of symptom presentation. The scientific project must include three parts: 1) a development phase, 2) an initial clinical validation phase, and 3) a description of how the validated biological measures will be incorporated into a risk stratification algorithm for persistent concussive symptoms. Development phase: In the development stage, the research project should focus on determining the sensitivity and specificity of one or more biological measures for prognosing and/or monitoring persistent concussive symptoms in an EMA population. Where feasible, each biological measure should be collected across all research sites. Initial clinical validation phase: A new independent cohort must be recruited and tested with the full set of biological measurements to be validated using the parameters and context of use obtained in the development phase.
Part 2. Full Text of Announcement
Section IV. Application and Submission Information
Overall Component
PHS 398 Research Plan (Overall)
Research Strategy: The Overall Research Strategy should describe the PCS-EMA CWOW's goals and objectives, background information, and the overall importance of including biological measures into the prognosis and monitoring of persistent concussive symptoms in an adolescent population. Describe the rationale for the proposed program and how each site is uniquely positioned to contribute world-class expertise and cutting-edge resources towards addressing the aims. Describe the rationale for choosing the biological measure of combination of biological measures including their feasibility for use in clinical settings and future clinical trials. Describe the need for any proposed research cores and how they will interact with the projects and the Administrative core. Explain the strategy for achieving the goals defined for the overall Center, how the research project and research cores relate to that strategy, and a transition plan for moving from the development phase to the initial clinical validation of the biological measures to a risk stratification algorithm. Clearly describe the context(s) under which the biological measure(s) could be used. The context(s) description should include but is not limited to: the point of care, clinical presentation of the population (e.g. patient groups with specific concussive symptom clusters), and mechanism of injury. The biological measures and risk stratification algorithm should be practical, efficient, and implementable in the appropriate clinical settings where patients present; e.g., emergency departments, urgent care clinics, sports medicine clinics, and primary care offices. Describe the plan for developing to a resource for the broader research community including policies for access and collaborations. Describe how the data sharing resource developed in this Center will serve to accelerate research and knowledge about persistent concussive symptoms in adolescents.
Modified to Read:
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Specific Research Objectives
This FOA solicits multicenter applications from multidisciplinary groups in order to develop, and then perform an initial clinical validation of three or more objective biological measures to improve accuracy for prognosticating and / or monitoring persistent concussive symptoms that result from concussion and/or repetitive head impacts in adolescent populations. The overarching goal of this program is to develop and validate biological measures that will improve prognosis of persistent concussive symptoms in EMA patients that accounts for and is sensitive to individual variability of symptom presentation. The scientific project must include three parts: 1) a development phase, 2) an initial clinical validation phase, and 3) a description of how the validated biological measures will be incorporated into a risk stratification algorithm for persistent concussive symptoms. Development phase: In the development stage, the research project should focus on determining the sensitivity and specificity of each of the biological measures or specific combinations of the biological measures for prognosing and/or monitoring persistent concussive symptoms in an EMA population. Where feasible, each biological measure should be collected across all research sites. Initial clinical validation phase: A new independent cohort must be recruited and tested with the full set of biological measurements to be validated using the parameters and context of use obtained in the development phase.
Part 2. Full Text of Announcement
Section IV. Application and Submission Information
Overall Component
PHS 398 Research Plan (Overall)
Research Strategy: The Overall Research Strategy should describe the PCS-EMA CWOW's goals and objectives, background information, and the overall importance of including biological measures into the prognosis and monitoring of persistent concussive symptoms in an adolescent population. Describe the rationale for the proposed program and how each site is uniquely positioned to contribute world-class expertise and cutting-edge resources towards addressing the aims. Describe the rationale for choosing each of biological measures or combination of biological measures including their feasibility for use in clinical settings and future clinical trials. Describe the need for any proposed research cores and how they will interact with the projects and the Administrative core. Explain the strategy for achieving the goals defined for the overall Center, how the research project and research cores relate to that strategy, and a transition plan for moving from the development phase to the initial clinical validation of the biological measures to a risk stratification algorithm. Clearly describe the context(s) under which the biological measure(s) could be used. The context(s) description should include but is not limited to: the point of care, clinical presentation of the population (e.g. patient groups with specific concussive symptom clusters), and mechanism of injury. The biological measures and risk stratification algorithm should be practical, efficient, and implementable in the appropriate clinical settings where patients present; e.g., emergency departments, urgent care clinics, sports medicine clinics, and primary care offices. Describe the plan for developing to a resource for the broader research community including policies for access and collaborations. Describe how the data sharing resource developed in this Center will serve to accelerate research and knowledge about persistent concussive symptoms in adolescents.
All aspects of this FOA remain unchanged.
Patrick SF Bellgowan, Ph.D.
Repair and Plasticity Cluster, National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1447
Email: psfb@mail.nih.gov