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The purpose of this announcement is to encourage grant applications for investigator-initiated prospective observational comparative effectiveness research (CER) to the National Institute of Neurological Disorders and Stroke (NINDS). The study must address questions within the mission and research interests of the NINDS and may evaluate preventive strategies, diagnostic approaches, or interventions including drugs, biologics, and devices, or surgical, behavioral, and rehabilitation therapies. Information about the mission and research interests of the NINDS can be found at the NINDS website (https://www.ninds.nih.gov/). Studies proposed should provide a cost-effective means of collecting data with a meaningful bearing on current clinical practice. Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to a observational study phase of up to five years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase for observational studies will permit both scientific and operational planning activities. Scientific planning activities include small-scale data collection to assess the feasibility and/or acceptability of data collection, storage, and planned analyses. Operational planning activities include, at a minimum, development of recruitment and retention strategies, case report forms, data management system and other tools for data and quality management. The UH3 phase of the award will support the conduct of investigator-initiated observational study.

The NIH Research Project Grant supports a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s). This Parent Notice of Funding Opportunity is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the appropriate Clinical Trials Required or Clinical Trial Optional NOFO. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.

The purpose of this notice of funding opportunity (NOFO) is to solicit applications for pilot projects to identify new druggable targets for pain within the understudied druggable proteome. Awards will support generation of preliminary data and/or tools around eligible understudied protein(s) listed in this NOFO. This NOFO is intended to jumpstart research on understudied proteins within the context of pain and pain management and provide applicants with sufficient funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins to identify new druggable targets for pain. This NOFO is part of the NIH Helping to End Addiction Long Term (HEAL) initiative to accelerate the development of novel medications to treat all aspects of the opioid addiction cycle, including progression to chronic use, withdrawal symptoms, craving, relapse, and overdose.

A central goal of the BRAIN Initiative is to understand how electrical and chemical signals code information in neural circuits and give rise to sensations, thoughts, emotions and actions. While currently available technologies can provide some understanding, they may not be sufficient to accomplish this goal. For example, non-invasive technologies are low resolution and/or provide indirect measures such as blood flow, which are imprecise; invasive technologies can provide information at the level of single neurons producing the fundamental biophysical signals, but they can only be applied to tens or hundreds of neurons, out of a total number in the human brain estimated at 85 billion. Other BRAIN FOAs seek to develop novel technology (RFA-NS-17-003) or to optimize existing technology ready for in-vivo proof-of-concept testing and collection of preliminary data (RFA-NS-17-004) for recording or manipulating neural activity on a scale that is beyond what is currently possible. This FOA seeks applications for unique and innovative technologies that are in an even earlier stage of development than that sought in other FOAs, including new and untested ideas that are in the initial stages of conceptualization. In addition to experimental approaches, the support provided under this FOA might enable calculations, simulations, computational models, or other mathematical techniques for demonstrating that the signal sources and/or measurement technologies are theoretically capable of meeting the demands of large-scale recording or manipulation of circuit activity in humans or in animal models. The support might also be used for building and testing phantoms, prototypes, in-vitro or other bench-top models in order to validate underlying theoretical assumptions in preparation for future FOAs aimed at testing in animal models.

The goal of this concept 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.

Eradicating latent reservoirs of HIV-1 within the body and achieving a sterilizing or functional cure have become priority areas in the AIDS field and NIH AIDS programs across many Institutes and Centers, including NIMH. In addition understanding the mechanisms of HIV- associated co-morbidities in the setting of effective anti-retroviral therapy (ART) is a major topic of interest in the field. HIV Associated CNS (central nervous system) co-morbidities continue to exist despite excellent virologic control in this compartment. HIV persistence and neuroinflammation also continues to observed in the CNS in the setting of ART. HIV targets the CNS early in infection, and HIV-infected individuals suffer from mild forms of neurological impairments even under antiretroviral therapy (ART). CD4+ T cells and monocytes mediate HIV entry into the brain and constitute a source for HIV persistence and neuronal damage. CD8+ T cells are also massively recruited in the CNS in acute infection to control viral replication.

Eradicating latent reservoirs of HIV-1 within the body and achieving a sterilizing or functional cure have become priority areas in the AIDS field and NIH AIDS programs across many Institutes and Centers, including NIMH. In addition understanding the mechanisms of HIV- associated co-morbidities in the setting of effective anti-retroviral therapy (ART) is a major topic of interest in the field. HIV Associated CNS (central nervous system) co-morbidities continue to exist despite excellent virologic control in this compartment. HIV persistence and neuroinflammation also continues to observed in the CNS in the setting of ART. HIV targets the CNS early in infection, and HIV-infected individuals suffer from mild forms of neurological impairments even under antiretroviral therapy (ART). CD4+ T cells and monocytes mediate HIV entry into the brain and constitute a source for HIV persistence and neuronal damage. CD8+ T cells are also massively recruited in the CNS in acute infection to control viral replication.

The purpose of this proposed Notice of Funding Announcement (NOFO) is to support development of biomarkers or clinical outcomes derived from digital health technology (DHT) for use in clinical trials for remote monitoring as primary or secondary endpoints. To improve clinical impact, increase statistical feasibility, and promote standardization, applicants will be expected to develop and test the digitally derived assessments in populations from at least three different diseases or conditions. Partnerships with non-profit patient advocacy organizations will be required.

The purpose of this initiative are to accelerate research leading to improved understanding and treatments for Guillain Barre Syndrome (GBS) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Responsive applications would propose studies of immunological mechanisms of nerve damage/dysfunction, contributing genetic/epigenetic factors, novel animal/cellular model systems, discovery of novel diagnostic or treatment response biomarkers, novel treatments or mechanisms of action of existing treatments.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may include Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral or rehabilitation therapies. All exploratory trials must contribute to the justification for and provide some of the data required to inform a future trial to establish efficacy (such as a Phase 3, Phase 4 or Pivotal trial). This FOA uses the UG3/UH3 mechanism. Only projects that provide satisfactory progress in the UG3 phase may move to the UH3 phase, as outlined below. For a drug, biologic or device that has not completed a Phase 1/Early Feasibility trial: The UG3 mechanism will be used to plan and execute the Phase I trial(s). If Phase 1 trials are successful, the UG3 will also include the planning phase of a Phase 2 trial. The UH3 mechanism will then support the execution of the Phase 2 clinical trial. Transition to the UH3 will depend on successfully reaching agreed upon milestones.