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This initiative is designed to promote discovery of cellular and molecular mechanisms that underlie brain blood vessels responses to passive anti-beta-amyloid immunotherapy that result in amyloid-related imaging abnormalities (ARIA). The goal is to establish an understanding of molecular mechanisms that can be targeted to protect the blood brain barrier (BBB), and thus the brain blood vessels, during therapeutic interventions that target beta-amyloid.

(Reissue of RFA-NS-16-021, PAR-18-413, RFA-NS-19-039) Diffuse brain white matter disease is highly prevalent in the elderly, and has been clinically associated with vascular contributions to cognitive impairment and dementia (VCID) in both men and women. Diffuse white matter disease is thought to include a variety of pathologies including demyelination and/or fiber loss due to multifocal infarction and local ischemia. It is often accompanied by arteriosclerosis in deep penetrating arteries, multiple infarcts in the basal ganglia, brainstem or cerebellum. Though most commonly extending out from the periventricular surfaces, it may also occur in subcortical white matter. Diffuse white matter disease is typically detected in clinical settings as hyperintensity on magnetic resonance imaging (MRI) or signal loss on computed tomography x-ray (CT) scan; diffuse white matter disease can be detected histologically as well, for example in human pathology and in studies using animal models. Despite the prevalence and potential significance of white matter disease for cerebrovascular disease etiology and cognitive outcomes, much remains to be learned about the cellular and molecular causes, regional vulnerability, and progression over time. The physiological consequences of diffuse white matter disease on local axon and neural circuit function are almost completely unknown. The purpose of this FOA is to address some of the many gaps in knowledge of the biologic mechanisms of the commonly occurring, cerebrovascular disease and age-related diffuse white matter disease at the molecular, cellular, tissue and brain circuit level. The ultimate goal of this fundamental research is to inform future efforts to reduce the burden of illness due to age-related vascular contributions to cognitive impairment and dementia.

Reissue: RFA-NS-21-023 - The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.

Reissue: RFA-NS-21-024: The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm

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.

NIAID announces the availability of funds for administrative supplement awards to promote the development of pediatric chemical research models and medical countermeasures (MCM) discovery under the Chemical Countermeasures Research Program (CCRP). There is currently an unmet need in understanding the natural history, pathophysiology, and treatment of critical illness in infants, children, adolescents, and young adults after exposure to highly toxic DHS-designated Chemicals of Concern (CoCs). The administrative supplement funds are intended to support pilot preclinical projects by CCRP-supported researchers that focus on 1) Basic research to elucidate mechanistic differences in susceptibility to CoCs between pediatric and adult populations and/or 2) Applied research towards the discovery and early development of pediatric-safe MCMs.

This BRAIN Initiative Notice of Funding Opportunity (NOFO) is to scale up efforts for viral, non-viral, transgenic, and gene regulatory element screening technologies and create reagent resources to access brain cell types. This NOFO is part of the BRAIN Initiative Armamentarium for Brain Cell Access transformative project. Reagent development efforts will apply gene transfer, gene regulation, genome engineering, activity sensor/effector, and atlasing technologies for use in both genetically tractable and less tractable systems, including primates and human tissue, which are relevant for future translational efforts. Reagent validation studies will provide feedback to improve scaled resources, informed by deeper understanding of neural gene transfer and regulation mechanisms. Precise targeting could ultimately aid in human disorders, for example, by providing access for gene editors to specific cell types to repair mutations.

This BRAIN Initiative Notice of Funding Opportunity (NOFO) is to support scaled reagent production and distribution facilities involving technologies to access brain cell types. Facilities for production and distribution of these reagents by a broad and diverse set of neuroscientists will be encouraged. This NOFO is part of the BRAIN Initiative Armamentarium for Brain Cell Access transformative project. Efforts will be supported to produce and distribute gene transfer, gene regulation, and genome engineering reagents for use in both genetically tractable and less tractable systems, including primates and human tissue, which are relevant for future translational efforts. Reagents to be produced and distributed are those designed and validated under other NOFOs from the Armamentarium transformative project.

Guided by the goals established in BRAIN 2025: A Scientific Vision and reinforced by the Advisory Council to the Director Working Group on BRAIN 2.0 Neuroethics Subgroup, this Notice of Funding Opportunity (NOFO) from the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is intended to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements supported by the BRAIN Initiative. This NOFO encourages research project grant applications from multi-disciplinary teams focused on key ethical issues associated with BRAIN Initiative supported research areas. Efforts supported under this NOFO are intended to be both complementary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative.