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Ethical considerations are intrinsic to the responsible conduct of neuroscience research and the translation of neuroscience advances (scientific and technological) into practice. This Notice of Special Interest (NOSI) highlights interest in receiving grant applications to advance research on ethical questions relevant to the NINDS mission of pursuing important work to gain a deeper understanding of the brain and nervous system to develop effective therapies for all people.

The goal of this effort is to support the development and validation of next generation platforms and analytic approaches to precisely quantify behaviors in humans and link them with simultaneously recorded brain activity. Tools used for analyzing behavior should be multi-modal and should be able to be linked to brain activity and thus have the accuracy, specificity, temporal resolution, and flexibility commensurate with tools used to measure and modulate the brain circuits that give rise to those behaviors. This phased award will support novel tool development (i.e., hardware/software) in the R61 phase and synchronization of novel tools for measuring behavior and human brain activity in the R33 phase.

This Brain-Behavior Quantification and Synchronization notice of funding opportunity (NOFO) seeks applications that bring together transdisciplinary teams and aim to 1) develop, validate, and apply cutting-edge tools and methods for minimally invasive, multi-dimensional, high-resolution objective measurement of behavior at the organismal level, with synchronous capture of dynamic environmental data; 2) develop advanced analytic approaches to integrate multidimensional behavioral, neural and environmental data; and 3) develop and test new theoretical and computational models aiming to advance understanding of behavior as a complex dynamic system. Proposed projects are expected to be designed with the capacity to integrate synchronously recorded neural data and/or inform existing models of neurobehavioral function, such as those developed with the support of the NIH BRAIN Initiative. This BRAIN Initiative NOFO is specifically soliciting applications proposing basic research involving human subjects aiming to reveal and understand fundamental principles underlying behavioral function, including research limited to observational studies or analysis of human data. Applications proposing research using exclusively non-human animal models should apply under the companion NOFO, RFA-DA-24-041. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP).

This Brain-Behavior Quantification and Synchronization notice of funding opportunity (NOFO) seeks applications proposing research aiming to 1) develop, validate, and apply cutting-edge tools and methods for minimally invasive, multi-dimensional, high-resolution measurement of behavior at the organismal level, with synchronous capture of changes in the organisms social or physical environment; and 2) develop computational methods that allow for integration of multidimensional behavioral and environmental data representing multiple timescales into a conceptual and/or computational model of behavior as a complex dynamic system. Proposed projects are also expected to be designed with the capacity to integrate synchronously recorded neural data and/or inform existing models of neurobehavioral function, such as those developed with the support of the NIH BRAIN Initiative. Research that falls under the definition of an NIH Clinical Trial is not allowed under this NOFO. Applicants interested in proposing mechanistic research in humans relevant to the above purpose should submit under the companion U01 NOFO, RFA-DA-24-040. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.

This is a non-competitive funding opportunity intended to fund a single award. The National Institute of Neurological Disorders and Stroke is announcing its intent to issue a single source cooperative agreementto the Hennepin Healthcare Research Institute to submit a renewal application to complete the phase II Hyperbaric Oxygen Brain Injury Treatment (HOBIT) clinical trial.

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.