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This NIH funding opportunity encourages 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 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. The program is part of the BRAIN Initiative and focuses specifically on next-generation devices for recording and modulation in the human central nervous system.

This funding opportunity encourages investigators to pursue small clinical trials to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. Clinical studies may consist of acute or short-term procedures deemed Non-Significant Risk (NSR) by an IRB, or Significant Risk (SR) studies requiring 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 due to the novelty of the device or its intended use. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements with device manufacturers willing to make such devices available, including devices not yet market approved but appropriate for clinical research.

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 goal of this funding opportunity is to increase the impact of the BRAIN Initiative by targeted dissemination and integration of validated BRAIN Initiative tools to investigators at institutions that historically have not been major recipients of NIH support. This will be accomplished by awards to PIs at resource-limited institutions (RLIs) who pair with BRAIN technologists to facilitate training and adoption of BRAIN Initiative technologies in the recipient laboratories. Goals include two-way knowledge transfer between the PI and BRAIN technologist and to increase the participation of PIs at RLIs in BRAIN Initiative relevant research. The program aims to bridge the gap between cutting-edge neuroscience technology development and its application at underserved research institutions, fostering broader participation in brain research across diverse institutional settings.