Notices of Funding Opportunities

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/.

The purpose of this funding opportunity announcement (FOA) is to support the development of novel tools and technologies through the Small Business Technology Transfer (STTR) program to advance the field of neuroscience research. This FOA specifically supports the development of novel neurotechnologies as well as the translation of technologies developed through The BRAIN Initiative® or through other funding programs, towards commercialization. Funding can support the iterative refinement of these tools and technologies with the end-user community, with an end-goal of scaling manufacture towards reliable, broad, sustainable dissemination and incorporation into regular neuroscience practice.

The purpose of this funding opportunity announcement (FOA) is to support the development of novel tools and technologies through the Small Business Innovation Research (SBIR) program to advance the field of neuroscience research. This FOA specifically supports the development of novel neurotechnologies as well as the translation of technologies developed through The BRAIN Initiative® or through other funding programs, towards commercialization. Funding can support the iterative refinement of these tools and technologies with the end-user community, with an end-goal of scaling manufacture towards reliable, broad, sustainable dissemination and incorporation into regular neuroscience research.

This R34 FOA solicits applications that offer a limited scope of aims and an approach that will establish feasibility, validity, or other technically qualifying results that, if successful, would support, enable, and/or lay the groundwork for a potential, subsequent Targeted Brain Circuits Projects - TargetedBCP R01, as described in the companion FOA (RFA-NS-18-009). Applications should be exploratory research projects that use innovative, methodologically-integrated approaches to understand how circuit activity gives rise to mental experience and behavior.

A central goal of the BRAIN Initiative is to develop new and improved perturbation technologies suitable for controlling specified cell types and circuits to modulate function in the central nervous system. This FOA seeks applications to systematically characterize, model, and validate the membrane, cellular, circuit, and adaptive-biological responses of neuronal and non-neuronal cells to various types of stimulation. Development of new technologies and therapies, as well as of disease models are outside the scope of this FOA. However, activities related to combining multiple recording modalities are allowed. As part of this program, investigators will be required to participate in a consortium to develop standards and model systems for the evaluation of current and next generation neuromodulation technologies.

The purpose of The BRAIN Initiative® Fellows (F32) program is to enhance the research training of promising postdoctorates, early in their postdoctoral training period, who have the potential to become productive investigators in research areas that will advance the goals of The BRAIN Initiative®. Applications are encouraged in any research area that is aligned with The BRAIN Initiative®, including neuroethics. Applicants are expected to propose research training in an area that clearly complements their predoctoral research. Formal training in analytical tools appropriate for the proposed research is expected to be an integral component of the research training plan. In order to maximize the training potential of the F32 award, this program encourages applications from individuals who have not yet completed their terminal doctoral degree and who expect to do so within 12 months of the application due date. On the application due date, candidates may not have completed more than 12 months of postdoctoral training. This Funding Opportunity Announcement (FOA) does not allow applicants to propose to lead an independent clinical trial, but does allow applicants to propose research experience in a clinical trial led by a sponsor or co-sponsor.

--- Notice to change the Application Due Dates on BRAIN Initiative - NOT-EB-18-005 - https://grants.nih.gov/grants/guide/notice-files/NOT-EB-18-005.html --- This FOA solicits new theories, computational models, and statistical tools to derive understanding of brain function from complex neuroscience data. Proposed tools could include the creation of new theories, ideas, and conceptual frameworks to organize/unify data and infer general principles of brain function; new computational models to develop testable hypotheses and design/drive experiments; and new mathematical and statistical methods to support or refute a stated hypothesis about brain function, and/or assist in detecting dynamical features and patterns in complex brain data. It is expected that the tools developed under this FOA will be made widely available to the neuroscience research community for their use and modification. Investigative studies should be limited to validity testing of the tools being developed.

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. The research should be offered as exploratory research and planning activities to establish feasibility, proof-of-principle and early-stage development that will later compete for continued funding under new or ongoing FOAs of the BRAIN Initiative or under NIH Institute appropriations. Projects should maximize opportunities to conduct innovative in vivo neuroscience research made available by direct access to brain recording and stimulating from invasive surgical procedures. In addition, projects that aim to implement novel methods of temporally-linked brain-behavior quantification in laboratory and real-world settings are encouraged. Awardees will join a consortium work group, coordinated by the NIH, to identify consensus standards of practice as well as supplemental opportunities to collect and provide data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community.

This FOA solicits applications for research projects that use innovative and methodologically-integrated approaches to understand how circuit activity gives rise to mental experience and behavior. The goal is to support projects that can realize a meaningful outcome within 5 years. Applications should address circuit function in the context of specific neural systems such as sensation, perception, attention, reasoning, intention, decision-making, emotion, navigation, communication, or homeostasis. Projects should link theory and data analysis to experimental design and should produce predictive models as deliverables. Projects should aim to improve the understanding of circuits of the central nervous system by systematically controlling stimuli and/or behavior while actively recording and/or manipulating dynamic patterns of neural activity. Projects can use non-human animal species, and applications should explain how the selected species offers ideal conditions for revealing general principles about the circuit basis of a specific behavior.

This funding opportunity announcement (FOA), in support of the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, aims to support early stage development of entirely new and novel noninvasive human brain imaging technologies and methods that will lead to transformative advances in our understanding of the human brain. The FOA solicits unusually bold and potentially transformative approaches and supports small-scale, proof-of-concept development based on exceptionally innovative, original and/or unconventional concepts.