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Awarded activities will facilitate the translation of novel recording and modulation technologies that can be used to treat and/or diagnose central nervous system (CNS) diseases and disorders and to better understand the human CNS, from proof of concept up to the stage of readiness for first in human (FIH) studies. Technologies may incorporate any signal modality (e.g., electrical, optical, magnetic, acoustic) or a combination thereof. Diverse team-based applications that integrate appropriate domains of expertise are encouraged.

This Notice of Funding Opportunity (NOFO) solicits applications to develop web-accessible data archives to capture, store, and curate data related to BRAIN Initiative activities. The data archives will work with the research community to incorporate tools that allow users to analyze and visualize the data, but the creation of such tools is not part of this NOFO. The data archives will use appropriate standards to describe the data, but the creation of such standards is not part of this NOFO. A goal of this program is to advance research by creating a community resource data archive with appropriate standards and summary information that is broadly available and accessible to the research community for furthering research.

The purpose of the NINDS Institutional Translational Research Training Program is to equip trainees with the knowledge and skills needed to advance basic research toward clinical application. These programs will support, students and/or postdocs conducting basic, disease-relevant research in an environment that includes 1) basic neuroscientists and clinicians who are actively engaged in collaborative research projects, 2) neuroscience researchers with expertise in translational processes who are conducting research designed to move basic discoveries toward clinical application and 3) relationships with industry and government regulatory agencies. Programs will have a cohesive educational approach to translational training in areas relevant to the NINDS mission, and in which students and postdocs learn the processes involved in translational research in the context of their individual projects. Programs supported by this FOA must include activities that ensure a thorough understanding of experimental design, strong statistical and analytical skills, and skills for communicating science with a wide variety of audiences. These programs are intended to be 2 years in duration and support training of one or more of the following groups: advanced predoctoral students, postdoctoral fellows and fellowship-stage clinicians. Upon completion of the program, trainees will be prepared to address basic research problems with an understanding of the requirements for translating discoveries into viable therapies.

This NOFO would support development and validation of novel clinically- and/or pathophysiologically-relevant human cellular models of ADRD. The cellular model systems would be expected to capture the multi-faceted pathologies and multiple cell types observed in ADRDs. Validation includes internal, face, construct, and predictive (to the extent possible) validation. These models can be developed/validated with the goal of supporting therapy development or better understanding of human disease mechanisms and mechanisms that uncover predisposition to developing neurodegenerative dementias. Human cellular models need to be novel, complex, and address a gap in the currently available models. Multidisciplinary teams will be highly encouraged. Leveraging the use of and depositing new cells into existing NIH cell repository resources will also be encouraged.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this National Insitute of Neurological Disorders and Stroke R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs.To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on research experiences, designed to foster the development of physicians as research scientists in areas relevant to the NINDS mission. The research experiences will prepare clinicians to successfully compete for individual NIH mentored career development awards, or where appropriate, independent research awards. This FOA will also support educational activities such that participants of the R25 are expected to attend and participate in an annual workshop specific to this FOA to present their work, discuss progress and plans towards transitioning to the next career stage and to network with other researchers and leaders in their fields. Such success will facilitate their transition from resident/fellow to physician-scientist, and will thus foster retention of a cadre of physician-scientists who will conduct research into the mechanisms of, etiology, and treatment of neurological diseases.

This NOFO would support investigations with a minimum of two relevant co-pathologies (e.g., tau, alpha-synuclein, TDP-43, TMEM106B, vascular), with optional risk factors and co-morbidities, to identify cellular and molecular mechanisms of how/why multi-proteinopathy interactions drive worsening neurodegenerative processes and phenotypic outcomes. Studies should examine co-pathology cellular and molecular interactions across brain regions and time in proximate cell population, across various intracellular dynamics and localization, and upstream and downstream from aggregated protein states to determine what events lead to worse phenotypic outcomes.

(Reissue PAR-21-058). The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

(Reissue PAR-21-056) The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

(Reissue PAR-21-057) The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.