Notices of Funding Opportunities

This funding opportunity announcement (FOA), in support of the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, aims to support transformative discoveries that will lead to breakthroughs in understanding human brain function. Guided by the long-term scientific plan, “BRAIN 2025: A Scientific Vision,” this FOA specifically seeks to support efforts that will revolutionize our understanding of the biological activity underlying, and bioinformatic content of, data collected using contemporary non-invasive functional brain imaging techniques. The hope is that these transformative discoveries will lead to breakthroughs in understanding the dynamic activity of the human brain.

The purpose of this Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative is to encourage applications that will develop and validate novel tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function. The new tools and technologies should inform and/or exploit cell-type and/or circuit-level specificity. Plans for validating the utility of the tool/technology will be an essential feature of a successful application. The development of new genetic and non-genetic tools for delivering genes, proteins and chemicals to cells of interest or approaches that are expected to target specific cell types and/or circuits in the nervous system with greater precision and sensitivity than currently established methods are encouraged. Tools that can be used in a number of species/model organisms rather than those restricted to a single species are highly desired. Applications that provide approaches that break through existing technical barriers to substantially improve current capabilities are highly encouraged.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue translational non-clinical studies and clinical studies for recording and/or stimulating devices to treat nervous system disorders and thereby better understand the human brain.The program will utilize a cooperative agreement mechanism to support the non-clinical studies necessary for the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and the subsequent small clinical study (e.g., Early Feasibility Study).Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical study. The small clinical study 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 study 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.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue a small clinical study to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and thereby 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 study 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 study 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 study to answer key questions about the function or final design of a device.

This Funding Opportunity Announcement (FOA) solicits grant applications in two related but distinct areas. The first area is in the development and testing of novel tools and methods of neuromodulation that go beyond the existing variations on magnetic or electrical stimulation, and that represent more than an incremental advance over existing electromagnetic approaches. The second distinct area that this FOA seeks to encourage is the optimization of existing electrical and magnetic stimulation methods.

The focus of this Funding Opportunity Announcement (FOA) is to better understand how existing non-invasive neuromodulation devices affect brain circuity. This information should shed light on dose/response relationships that could be used for neuroscience applications and clinical interventions.

Although invention and proof-of-concept testing of new technologies is a key component of the BRAIN Initiative, to achieve their potential these technologies must also be optimized through feedback from end-users in the context of the intended experimental use. This seeks applications for the optimization of existing and emerging technologies and approaches that have potential to address major challenges associated with recording and manipulating neural activity, at or near cellular resolution, at multiple spatial and temporal scales, in any region and throughout the entire depth of the brain.This FOA is intended for the iterative refinement of emergent technologies and approaches that have already demonstrated their transformative potential through initial proof-of-concept testing, and are appropriate for accelerated development of hardware and software while scaling manufacturing techniques towards sustainable, broad dissemination and user-friendly incorporation into regular neuroscience practice.

The purpose of this Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative is to encourage applications that will develop and validate novel tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function. The new tools and technologies should inform and/or exploit cell-type and/or circuit-level specificity. Plans for validating the utility of the tool/technology will be an essential feature of a successful application. The development of new genetic and non-genetic tools for delivering genes, proteins and chemicals to cells of interest or approaches that are expected to target specific cell types and/or circuits in the nervous system with greater precision and sensitivity than currently established methods are encouraged. Tools that can be used in a number of species/model organisms rather than those restricted to a single species are highly desired. Applications that provide approaches that break through existing technical barriers to substantially improve current capabilities are highly encouraged.

Understanding the dynamic activity of neural circuits is central to the NIH BRAIN Initiative.This FOA seeks applications for proof-of-concept testing and development of new technologies and novel approaches for large-scale recording and manipulation of neural activity to enable transformative understanding of dynamic signaling in the nervous system.In particular, we seek exceptionally creative approaches to address major challenges associated with recording and manipulating neural activity, at or near cellular resolution, at multiple spatial and/or temporal scales, in any region and throughout the entire depth of the brain.It is expected that the proposed research may be high-risk, but if successful could profoundly change the course of neuroscience research.

Invasive surgical procedures provide the unique ability to record and stimulate neurons within precisely localized brain structures in humans. Human studies using invasive technology are often constrained by a limited number of patients and resources available to implement complex experimental protocols and are rarely aggregated in a manner that addresses research questions with appropriate statistical power. Therefore, this FOA seeks applications to assemble integrated, multi-disciplinary teams to overcome these fundamental barriers. Projects should investigate high-impact questions in human neuroscience and disorders of the human nervous system. The research should be offered as experimental projects, or exploratory research and planning activities, for building teams, generating data and empirical results that will later compete for continued funding under new or ongoing FOAs of the BRAIN Initiative or under NIH Institute appropriations.