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This funding opportunity announcement (FOA) invites applications for mentored career enhancement (K18) awards in research areas that are highly relevant to the NIH BRAIN Initiative. This career enhancement program will support development of research capability for the BRAIN Initiative, with specific emphasis on cross-training independent investigators in a substantively different area of neuroscience, neuroethics, or in a quantitative and physical discipline (e.g., physics, chemistry, engineering, computer science, mathematics); and vice versa, cross-training independent investigators trained in a quantitative or physical discipline proposing to gain in-depth training in a high-priority area of neuroscience. The research project conducted under this K18 should enhance the candidates ability to significantly contribute to or lead projects that investigate questions central to the goals of the BRAIN Initiative. Eligible candidates are independent investigators at any faculty rank or level.

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 largescale 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.

Although invention and proof-of-concept testing of new technologies are 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 Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational and clinical studies for recording and/or stimulating devices to treat nervous system disorders and better understand the human brain. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and a subsequent small clinical study (e.g., Early Feasibility 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 nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. 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 purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators 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 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.

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.

The purpose of this FOA is to solicit applications that propose basic and/or translational research studies regarding the developing neurovascular unit, perinatal stroke injury/repair response, and/or stroke related etiologies and risk factors. Research addressing vascular, hemostatic, hematopoietic, and/or immune cell activities in the developing brain is of particular interest. The intent is to stimulate research that will identify therapeutic targets in perinatal stroke.

The SCORE Program is a developmental program designed to increase the research competitiveness of faculty and research capacity of institutions with an explicitly stated historical mission and/or a demonstrated historical track record of training and graduating students from backgrounds underrepresented in biomedical research. Eligible institutions must award science degrees to undergraduate (B.S. or B.A.) and/or graduate students (M.S. or Ph.D.) and have received less than 6 million dollars per year of NIH R01 support (total costs) in each of the last 2 fiscal years.

The SCORE Program is a developmental program designed to increase the research competitiveness of faculty and the research base at institutions with an explicitly stated historical mission and/or a demonstrated historical track record of training and graduating students from backgrounds underrepresented in biomedical research. Eligible institutions must award science degrees to undergraduate (B.S. or B.A.) and/or graduate students (M.S. or Ph.D.) and have received less than 6 million dollars per year of NIH R01 support (total costs) in each of the last 2 fiscal years.