Approved Initiative Concepts

A concept describes the basic purpose, scope, and objectives of a potential solicitation of grants or contracts. Approved concepts are posted here to alert researchers to areas of NINDS research interest and to give researchers maximal lead time to plan projects. Please note that not every concept will lead to a Notice of Funding Opportunity (NOFO). NINDS bases this determination on scientific and programmatic priorities and the availability of funds. Furthermore, even if they do convert, the actual NOFO may differ in certain details from its originating concept.

The National Advisory Neurological Disorders and Stroke (NANDSC) Council conducts all NINDS concept clearances.

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Council Round Concept Title Point of Contact Description Link to Council Discussion Category
2024/01 Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access Lumy Sawaki-Adams This concept aims to encourage scientific research of amyotrophic lateral sclerosis (ALS) using expanded access (EA) data for investigational drugs or biological products. The concept aims to focus on EA for intermediate size populations of patients living with ALS who are not eligible for ongoing clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of ALS. n/a
2024/01 NINDS Faculty Development Award to Promote Diversity in Neuroscience Research Lauren Ullrich This concept aims to provide intensive, supervised career development and scientific mentoring experience for promising junior investigators within the initial three years of their faculty tenure track, or equivalent, position. The concept also aims to support investigators from diverse backgrounds, including those from groups underrepresented in biomedical research by offering protected time from teaching and other duties along with other resources. The overarching goal is to enable junior investigators to launch their independent research careers and position themselves competitively for new research project funding. n/a
2024/01 Materials to Enhance Training in Experimental Rigor (METER) Devon Crawford This concept aims to support the development of innovative educational materials incorporated into an online resource to promote awareness, understanding, and practice of fundamental principles of rigorous biomedical research. These materials would be added to the resource being developed by the Creating an Educational Nexus for Training in Experimental Rigor (CENTER) to build a one-stop shop for these principles and practices. n/a
2024/01 Summer Research Education Experience Program Marguerite Matthews This concept aims to support creative educational activities with a primary focus on research experiences for high school or undergraduate students or science teachers during the summer academic break. This would support educational activities that foster a better understanding of biomedical, behavioral, and clinical research to attract young students to careers in science and enhance science literacy. n/a
2024/01 Support of Research Excellence (SuRE) Program Lauren Ullrich The Support of Research Excellent (SuRE) concept aims to build research capacity by developing and sustaining research excellence at under-resourced institutions with limited NIH research funding. This would support investigator-initiated research with strong student participation and provide SuRE-eligible institutions with tools and resources to establish research infrastructure. n/a
2024/01 Child Neurologist Career Development Program (CNCDP) K Paul Rezaizadeh This concept aims to provide support, mentoring, oversight, knowledge and skills required for the research career development of junior pediatric neurology investigators that support research relevant to the mission of NINDS. The concept also aims to increase diversity in pediatric neurology research. This overarching goal of this concept is to build a cadre of pediatric neurologists trained to conduct outstanding research into neurological disorders of children. n/a
2024/01 Next Generation Preclinical Models of NeuroHIV in the combined antiretroviral therapy (cART) Era Will Daley This concept aims to support the development of preclinical models that more accurately represent the clinical state of chronic HIV infection in the context of stable combined antiretroviral therapy (cART) in the central nervous system. This concept would support research that focuses on the development and early-stage validation of next-generation humanized small animal models and human cellular microphysiological models. The goal of this concept would be to improve the translational relevance of HIV preclinical studies that focus on central nervous system dysfunction during cART. n/a
2024/01 NINDS Program Project Grant Alisa Schaefer This concept aims to support projects that conduct innovative, interactive research to answer significant scientific questions via partnerships between outstanding scientists who might not otherwise collaborate. The concept would support group research of several interdependent highly meritorious projects which would offer strong scientific advantages over the same projects researched individually. n/a
2024/01 Joint NINDS/NIMH Exploratory Neuroscience Research Alisa Schaefer This concept aims to support the early and conceptual stages of exploratory and innovative research projects that fall within the missions of the NINDS and NIMH. This would support riskier, novel avenues of investigation that have the potential to bring about breakthroughs in the understanding of neuroscience, or develop high-value techniques, agents, methodologies, or models. n/a
2024/01 Single Source for completion of the Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial Gretchen Scott This concept aims to support the Hyperbaric Oxygen Brain Injury Treatment (HOBIT) trial, an ongoing phase II study looking at whether hyperbaric oxygen therapy (HBO) treatment may prove beneficial in improving outcomes for patients who suffer severe brain injury. Due to the COVID-19 pandemic and the resulting impact on crucial support staff (ICU nurses, respiratory therapists, and HBO technicians), the trial has faced significant enrollment challenges. The overarching goal of this concept is to allow the additional time and resources needed to complete the HOBIT trial. n/a
2024/01 NINDS Ruth L. Kirschstein National Research Service Award (NRSA) for Training of Postdoctoral Fellows (F32) Michael Tennekoon This concept aims to support outstanding scientific training of promising candidates beginning a postdoctoral training period in a laboratory or research environment with exceptional mentors. The overarching goal is to foster early, goal-directed planning and encourage proposals for creative, bold ideas that have the potential for significant impact. Furthermore, the concept aims to prepare the postdoctoral candidates to launch independent research in areas that will advance the goals of the NINDS mission. n/a
2024/01 The NINDS Human Cell and Data Repository Rebecca Price This concept aims to support the NINDS Human Cell and Data Repository (NHCDR) as a resource for investigators utilizing fibroblasts and induced pluripotent stem cells (iPSCs) to advance the study of neurological disorders. The overarching goal of this concept is to support and maintain the centralized repository, NHCDR, that is broadly available to the scientific community and supports and advances the NINDS mission to reduce duplicative efforts, increase standardization, and ensure high quality iPSC generation. n/a
2024/01 Institutional Research Training Program for Neurological Health Disparities/Health Equity (HD/HE) Research Tish Weigand AND Cheryse Sankar This concept aims to support institutional research training programs to equip early-career researchers with the knowledge and skills needed to conduct research related to neurological health disparities and health equity (HD/HE). The overarching goal of this concept is to provide training and mentoring opportunities for early career researchers to expand the cadre of investigators in neurological HD/HE. Presentation and Discussion - Cheryse Sankar and Tish Weigand begins at 3:01:00 and ends at 3:19:00
2024/01 NINDS Exploratory Grant Program in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Research Vicky Whittemore This concept aims to support the planning and initiation of collaborative efforts to advance research on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). It would provide support for groups of investigators to come together to develop synergistic, proof-of-concept research to address gaps in ME/CFS research. The overarching goal of this concept is to foster collaborative, interdisciplinary teams that complete rigorous research that makes scientific contributions to our understanding of the pathophysiology and potential new treatments for ME/CFS. n/a
2024/01 Blueprint Neurotherapeutics Network (BPN) Biologic-based Drug Discovery and Development for Disorders of the Nervous System Chris Boshoff The goal of this concept is to support biologic-based drug discovery and development for nervous system disorders, from lead optimization through phase I clinical testing. This concept aims to de-risk discovery and early development projects to interest outside investment and complete late-stage development to bring novel neurotherapeutics to market. n/a
2024/01 Small Business Innovation Research Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research Emily Caporello This concept aims to utilize Small Business Innovation Research (SBIR) funding to support small businesses in furthering clinical development of NINDS-relevant therapeutics and technologies. This concept also aims to support commercialization by enabling partnerships between small business awardees and third-party investors and/or strategic partners. n/a
2024/01 Small Business Innovation Research Phase II Grants (Phase IIB) for Pre-Clinical Research Emily Caporello This concept aims to utilize Small Business Innovation Research (SBIR) funding to support small businesses in furthering pre-clinical development of NINDS-relevant therapeutics and technologies. This concept also aims to support commercialization by enabling partnerships between small business awardees and third-party investors and/or strategic partners. n/a
2024/01 Innovation Grants to Nurture Initial Translational Efforts (IGNITE) Becky Roof The goal of this concept is to support early-stage therapy development and encourage translation of research discoveries into new treatments for disorders within the NINDS mission. The overarching goal is to support projects that would be able to meet the entry criteria for later-stage therapeutic development programs, such as the NIH Blueprint Neurotherapeutic Network for Small Molecules and Biologics. n/a
2024/01 Protective strategies to reduce Amyloid Related Imaging Abnormalities (ARIA) after anti-AB immunotherapy Francesca Bosetti AND Lanier Heyburn This concept aims to support investigations to better understand the mechanisms underlying blood-brain barrier dysfunction after anti-β-amyloid immunotherapy as well as studies to develop potential protective interventions to reduce severe adverse events due to Amyloid Related Imaging Abnormalities (ARIA), with or without specific risk factors, such as APOE4 carrier status. Research areas of particular interest include but are not limited to studying the underlying mechanisms of the effects of ApoE4 on neurovascular dysfunction and inflammatory response. n/a AD/ADRD
2024/01 AD/ADRD Advanced Postdoctoral Career Transition Award to Promote Diversity Lauren Ullrich This concept aims to enhance workforce diversity by supporting a mentored research experience (K99), followed by independent research (R00) for postdoctoral fellows working in Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) research areas, including research on Alzheimer’s disease, mixed etiology dementias, vascular contributions to cognitive impairment and dementia (VCID), Lewy body dementia (LBD), and frontotemporal degeneration (FTD). The overarching goal of this concept is to enable postdoctoral fellows to launch competitive, independent research careers. n/a AD/ADRD
2024/01 Functional Validation of Novel Targets in ADRD Pascal Laeng The goal of this concept is to improve confidence in the efficacy and safety of novel targets to trigger customized therapeutic strategies in Alzheimer’s Disease-Related Dementias (ADRD). This concept aims to support the development of customized technologies, models, and protocols to modulate the expression or activity of target candidate(s) and monitor their functional biological consequences. Those initial setups would help researchers to reproducibly measure and cross-validate the positive and potential negative impacts of the target modulation in different modalities. n/a AD/ADRD
2024/01 Optimization of Genome Editing Therapeutics for Alzheimer's Disease-Related Dementias (ADRDs) Tim LaVaute This concept aims to support early translational research focused on somatic cell genome editing for ADRDs. It would support the demonstration of delivery of a genome editing package to appropriate cell types in the central nervous system, show in vivo efficacy of the editing package in Alzheimer's Disease-Related Dementias (ADRD) animal and other relevant model(s), and envision feasible scaled-up manufacturing of the editing package, with the goal of identifying a fully optimized clinical candidate therapeutic at the end of the funding period. n/a AD/ADRD
2024/01 Mechanistic Basis of Diffuse White Matter Disease in Vascular Contributions to Cognitive Impairment and Dementia (VCID) Rod Corriveau This concept aims to support hypothesis-testing research to elucidate hemodynamic, cellular, and molecular mechanisms that underlie diffuse white matter disease of vascular origin including multifocal, small, and silent brain infarcts that may contribute to cognitive impairment and dementia. Despite the prevalence and potential significance of white matter disease for cerebrovascular disease etiology and cognitive outcomes, much remains to be learned about the hemodynamic, cellular, and molecular causes, regional vulnerability, and progression over time. Overall, this concept aims to inform future efforts to reduce the burden of illness due to VCID. n/a AD/ADRD
2024/01 Neuropathological Interactions Between COVID-19 and ADRD Will Daley This concept aims to explain the mechanisms by which COVID-19 interacts with and/or modulates ADRDs-relevant phenotypes. This would be achieved by focusing on ADRD interactions with COVID-19, such as incorporating ADRD outcomes, risk factors, pathologies, or relevant comorbidities. Research of interest also may address how COVID-19 impacts CNS pathology and cognitive outcomes when ADRD pathology is already well developed, how COVID-19 accelerates ADRD pathology and cognitive deficits at early time points in a prodromal model, how COVID-19 predisposes for ADRD and/or interacts with relevant comorbid conditions and ADRD risk factors, and how pre-existing ADRD enhances the risk of more severe post-COVID-19 neurological outcomes. n/a AD/ADRD
2024/01 Tools and resources to understand the vascular pathophysiology of in vivo neuroimaging findings in Amyloid Related Imaging Abnormalities (ARIA) Carlos Faraco This concept aims to encourage the development and sharing of tools and resources—including biomarkers, biomedical materials, innovative technologies, and standardized methods and protocols—that further enable combined analysis of human in vivo MRI, ex vivo MRI, and postmortem neuropathology data to understand the underlying pathophysiology of spontaneous and anti-Aβ monoclonal antibodies (MABs) induced Amyloid Related Imaging Abnormalities (ARIA) in Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD). Additionally, this concept aims to encourage the development and dissemination of tools and resources that may demonstrate potential usefulness in screening for ARIA risk factors. n/a AD/ADRD
2024/01 Administrative Supplements to Promote Diversity for NINDS AD/ADRD Amber McCartney This concept aims to encourage applications for research supplements to promote diversity in health-related research, and more specifically to encourage institutions to diversify their student populations by enhancing the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences. This would be achieved by providing administrative supplements to currently active NIH research grants to provide support for AD/ADRD research experiences for underrepresented individuals to enhance the diversity of the research workforce. n/a AD/ADRD
2024/01 Mechanistic Investigations into ADRD Multiple Etiology Dementias Linda McGavern This concept seeks to examine Alzheimer’s Disease (AD) and Alzheimer’s Disease Related Dementias (ADRDs) co-pathology to understand cellular and molecular interactions across brain regions across various intracellular localizations, to determine what events lead to worse phenotypic outcomesCo-pathologies commonly occur in AD/ADRDs, and having multiple pathologies results in worse cognitive impairment and dementia outcomes; however, the mechanisms behind this are unclear. More knowledge is needed around what are distinct and shared mechanistic pathways, disrupted circuitry, and interactions that result in cognitive impairment. n/a AD/ADRD
2024/01 Investigating Distinct and Overlapping Mechanisms in TDP-43 Proteinopathies, including in LATE, FTD, and other AD/ADRD Linda McGavern This concept aims to establish deeper mechanistic insight and causal relationships between TDP-43 pathology and phenotypic outcomes, as well as mechanistic interactions between TDP-43 and other ADRD-relevant co-pathologies that may impact its regulation and function. TDP-43 proteinopathies manifest differently clinically, and more understanding of basic biology is needed to understand underlying mechanisms, determine if/how this TDP-43 pathology may be causally involved in neurodegeneration and cognitive deficits, and discover how it may contribute to the clinical heterogeneity. Additionally, this concept seeks to compare TDP-43 proteinopathies to further understand distinct and overlapping mechanisms in these syndromes and to discover what is causally involved in cognitive decline and dementia. n/a AD/ADRD
2024/01 Mechanisms of Cognitive Fluctuations in ADRD Populations Deb Babcock This concept seeks to encourage research to understand the pathophysiology underlying cognitive fluctuations in ADRD populations. Cognitive fluctuations can occur in many types of dementia and are a core clinical feature of dementia with Lewy bodies, yet these events are poorly understood. Cognitive fluctuations can last from seconds to days, are unpredictable, and are associated with poor daily functioning for the patient. n/a AD/ADRD
2024/01 Clinical Trial Readiness to Understand and Develop Solutions to social, ethical, and behavioral implications (SEBI) Barriers to Health Equity in ADRD Richard Benson AND Rebecca Hommer AND Carolina Mendoza-Puccini This concept aims to support research to establish clinical trial readiness for community-driven interventions to understand and develop solutions to barriers to equity in ADRD outcomes among NIH-designated populations that experience health disparities. The concept would support research projects that would consider the social, ethical, and behavioral implications (SEBI) related to assessing risk for, diagnosis of, or treatment of ADRD among underserved and marginalized populations to identify potential interventions that increase equitable outcomes, as measured in future clinical trials. n/a AD/ADRD
2024/01 Investigational New Drug (IND)-enabling Studies and Clinical Trials for Genome Editing Therapeutics for ADRD Tim LaVaute This concept aims to support Investigational New Drug (IND)-enabling studies for the preparation and submission of an IND for a genome editing therapeutics for AD/ADRD, followed by a Phase I clinical trial to test the therapeutic. Although multiple pathways contribute to disease onset and progression in the ADRDs, several common and rare genetic variants and epigenetic changes have been identified as potential targets for therapeutic interventions. The emergence of CRISPR-based in vivo genome editing approaches holds significant potential for the development of therapeutic options for a broad range of ADRD patients. n/a AD/ADRD
2024/01 ADRD Risk and Disease Following Nervous System Exposures at Biological Interfaces with the Environment David Jett This concept aims to determine how exposures at innervated human surfaces affect ADRD disease mechanisms and phenotypic outcomes. These exposures include toxins and toxic chemicals, viral and other pathogens, and other environmental exposures. Supported research will focus on interactions between the outside world and innervated biological surfaces such as in the gut, the mouth, throat, lungs, nasal passages, skin, and other surfaces that interface with the environment. n/a AD/ADRD
2024/01 Interaction Between Environmental Factors and Lewy Body Dementia David Jett The goal of this concept is to identify novel and potentially modifiable targets of Lewy body dementia (LBD). It would support research that firmly establishes causal links between environmental factors and Lewy body formation. The overarching goal is to reveal the mechanistic basis for how exogenous environmental factors can lead to LBD. n/a AD/ADRD
2024/01 Including Validated ADRD Biomarker Measures and APOE Genotype Status in ADRD Human Subjects Research Studies Amber McCartney The goal of this concept is to support the inclusion of validated ADRD fluid-based biomarker measures and APOE genotype status in existing Alzheimer's Disease and Alzheimer's Disease-Related Dementias (AD/ADRD) cohort studies. Adding these new data to existing studies should enhance the clinical and scientific impact both now and in the future via data sharing. These biomarker additions and genotyping may also directly increase value of the study by predicting treatment response, monitoring disease progression, and enhancing understanding of therapeutic interventions. n/a AD/ADRD
2024/01 NINDS AD/ADRD Advanced Postdoctoral Career Transition Award Amber McCartney This concept aims to ensure a diverse pool of highly trained scientists is available in fields supported by the National Alzheimer’s Project Act including, Alzheimer’s disease, frontotemporal dementias, Lewy Body dementia, vascular contributions to cognitive impairment and dementia, and mixed/multiple etiology dementia. This would be achieved by supporting the transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions into independent, tenure-track or equivalent faculty positions in Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) research areas. n/a AD/ADRD
2024/01 Development and Validation of Human Cellular Models for ADRD Linda McGavern AND Frank Shewmaker This concept aims to support developing and validating novel, complex, and pathophysiologically relevant human cellular models of Alzheimer’s Disease-Related Dementias (ADRD) to address a gap in currently available models. This would be achieved with cellular model systems that capture the multi-faceted pathologies and multiple cell types observed in ADRDs, and human cellular models that could be developed and validated. The overarching goal of this concept is to support therapeutic development or a better understanding of human disease mechanisms and mechanisms that uncover predisposition or resilience to developing neurodegenerative dementias. n/a AD/ADRD
2024/01 Harmonization of Neuropathology data: NIH Neurobiobank AD/ADRD donors Daniel Miller This concept aims to establish a harmonized, interoperable, and accessible NIH Neurobiobank neuropathology (NP) dataset and accompanying user interface, by using and further optimizing the extraction pipeline established in the pilot project. NINDS recently supported a pilot project testing the feasibility of harmonizing NIH NP data, by focusing on NP reports from donors with a clinical diagnosis of Parkinson’s disease. The pilot project established a semi-automated pipeline to clean, curate, and harmonize diagnostic and findings data, while establishing a data dictionary that is directly interoperable with existing relevant Common Data Elements frameworks. n/a AD/ADRD
2024/01 Integrative Multi-Omic Profiling for Lewy Body Dementia Christine Swanson-Fischer This concept aims to support research on genetic and molecular characterization of Lewy Body Dementia (LBD). This would be achieved by supporting multi-omic molecular profiling which may include whole genome sequencing, longitudinal bulk-transcriptomics, longitudinal matched plasma, and cerebrospinal fluid proteomic analysis, and post-mortem single-cell RNA sequencing (scRNAseq), which will be generated and paired with harmonized longitudinal clinical data. n/a AD/ADRD
2024/01 Mechanistic Investigations into AD/ADRD associated protein structures in biological settings George Umanah This concept seeks to support studies to develop and/or use methodologies for in-cell structural biology to address questions that have previously been experimentally impossible. This would be achieved by determining Alzheimer's Disease and Alzheimer's Disease-Related Dementias (AD/ADRD) linked macromolecular structures in native (healthy and pathological) settings. The proposed methodology could provide atomic-level precision information on the identity, dynamics and relative abundance of macromolecular species associated with AD/ADRDs and how pathological environments influence dynamics and structural conformations. n/a AD/ADRD
2024/01 Enhancing the Clinical Pain Research Workforce Meera Raja (meera.raja@nih.gov) This concept aims to bolster the clinical pain research workforce by providing research and career development time for early-state investigators and clinicians. While HEAL has made investments in building the clinical pain research workforce through existing programs, these programs have primarily focused on those in the earliest career stages (e.g., graduate students, postdoctoral trainees, and new faculty). This concept would support researchers beyond those stages but have yet to transition to full independence. n/a HEAL
2024/01 HEAL Data Ecosystem Renewal Jessica Mazerik The concept aims to make data management and sharing of HEAL data more efficient by centralizing the efforts. This concept would support HEAL investigators in meeting their data sharing requirements and aligning with the HEAL open access policy. Additionally, this concept aims to facilitate resource development, promote best practices for data management and deposition, and provide infrastructure and support to ensure the findability and accessibility of HEAL datasets. n/a HEAL
2024/01 Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain Laura Wandner This concept aims to leverage existing HEAL Initiative clinical research programs to train investigators new to pain research in the mechanics, techniques, and best practices of clinical pain research. It would support early career individuals in expanding their clinical pain research experience and gaining access to the tools and skills needed to prepare them for a career in clinical pain research. The overarching goal is to maximize the impact of HEAL Initiative programs on current and future research endeavors. n/a HEAL
2024/01 HEAL Initiative: Studies to Enable Analgesic Development Julia Bachman This concept aims to support the development of safe, effective, and non-addictive therapeutics to treat pain. This concept would support initial translational efforts that will facilitate a drug discovery program and advance projects to the point where they meet the entry criteria for the Pain Therapeutics Development Program. The overarching goal is to support the development of scientifically sound assays, identify promising small molecule or biologic starting points for optimization, and fill specific gaps needed to warrant further investment. n/a HEAL
2024/01 HEAL Initiative: Coordinated Approaches to Pain Care in Health Care Systems Laura Wandner This concept aims to utilize implementation science methodology to bring evidence-based coordinated pain care models into a variety of public and private health care systems (HCS) where this type of care does not exist or has limited uptake, with an emphasis on populations with greatest need. This concept also aims to address the biopsychosocial model of pain through studies to implement coordinated and personalized care for complex chronic pain conditions. n/a HEAL
2023/05 Wellstone Centers Glen Nuckolls The goal of this concept is to support Wellstone Muscular Dystrophy Centers that focus on collaborative basic, translational, and clinical research and provide important resources that can be used by the national muscular dystrophy research communities. The Centers also aim to provide outstanding environments for the training of new researchers capable of addressing high priority objectives in muscular dystrophy research. Center investigators are expected to participate in important community outreach efforts to increase awareness of their research activities in the patient and advocacy communities and to incorporate community perspectives into patient-centered research. n/a
2023/05 NINDS Institutional Research Training Program Stephen Korn The goal of this concept is to provide outstanding research training to dissertation-stage predoctoral students and/or postdoctoral fellows in areas relevant to the NINDS mission. This concept aims to encourage the creation of training programs that produce well-trained neuroscientists with the skills and knowledge to make significant contributions to biomedical research. Programs are expected to provide a strong foundation in experimental design, statistical methodology, quantitative analysis, and dedicated mentorship. Furthermore, the concept aims to emphasize the promotion of diversity and inclusivity and efforts to provide family-friendly policies, appropriate protections for students, and support for faculty training efforts. n/a
2023/05 NINDS Research Education Program for Residents and Fellows in Neurological Disorders and Stroke and Administrative Supplement for the NINDS Research Education Program Stephen Korn The goal of this concept is to provide clinicians with the time and tools to successfully compete for individual career development awards and research grants. Such success will facilitate their transition from resident/fellow to physician-scientist and will thus foster retention of a cadre of physician-scientists who will conduct research into the mechanisms that underlie, and treatment of, neurological diseases and disorders. n/a
2023/05 NIH Blueprint Neurotherapeutics Network (BPN) Chuck Cywin The goal of this concept is to combine the strengths of NIH and industry expertise in drug discovery and development to advance investigator-initiated small molecule drug discovery projects with neuroscience clinical indications while adding value by protecting the grantee’s intellectual property (IP) through NIH Blueprint Neurotherapeutics Network (BPN). Furthermore, this concept aims to de-risk those drug discovery and early development projects to the point where outside investment can take over and complete the late-stage development and bring novel neurotherapeutics to market. n/a
2023/05 NINDS Exploratory Clinical Trials for Small Business Emily Caporello The goal of this concept is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Technology Transfer (STTR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The STTR supports early-stage clinical trial research related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral, or rehabilitation therapies. The concept aims to prepare early-stage, promising technologies for larger multi-site studies supported through NINDS clinical trial networks or through a transition to private funding. n/a
2023/05 Analysis of data in the COVID-19 Neuro Databank-Biobank Barbara Karp The goal of this concept is to invite applications that aggregate and analyze existing data in the COVID-19 Neuro Databank-Biobank (NeuroCOVID Project). The NeuroCOVID Project was established in 2020 to serve as a robust national resource to understand the neurological complications associated with COVID-19 and the effects of COVID-19 on pre-existing neurological conditions. This concept aims to support hypothesis-driven applications to further scientific knowledge of neurological complications of COVID-19 by using this de-identified database. The data may be combined with other databases. n/a
2023/05 Vascular Contributions to Cognitive Impairment and Dementia (VCID) Center Without Walls (CWOW) for Understanding and Leveraging Small Vessel Cerebrovascular Disease Mechanisms in ADRD Rod Corriveau This concept aims to support research that will, in parallel in human-based and model-based studies, advance understanding of basic disease-related molecular mechanisms related to cerebrovascular disease that contributes to clinical dementia diagnoses. Furthermore, this concept encourages applications focusing on atherosclerosis, arteriolosclerosis, and cerebral amyloid angiopathy (CAA), as well as how these disorders respond to potential and approved therapeutics against dementia. n/a AD/ADRD
2023/05 Validating Digital Health Technologies for Monitoring Biomarkers in ADRD Clinical Trials Carol Taylor-Burds The goal of this concept is to encourage development and validation of digital monitoring biomarkers and digital functional/performance outcome for monitoring symptoms or aspects of Alzheimer's Disease Related Dementias (ADRD) that impact quality of life. This concept will encourage applications from partnerships between academics and companies that manufacture wearable digital devices (“digital health technologies (DHTs)”) to develop and verify the analysis/algorithms or software to accurately detect and measure the physiological or functional aspects of interest. In the second phase, applicants will be expected to conduct a prospective longitudinal study to validate the measurements of the biomarker or functional/performance outcome in two or more ADRD populations. n/a AD/ADRD
2023/05 Role of Environmental Stress in the Health Inequities of Alzheimer's Disease-Related Dementias (ADRD) David Jett This concept aims to increase our knowledge of how environmental stressors such as heat, crowding, air quality, noise, violence, and adverse childhood experiences in lower resourced communities affect Alzheimer’s Disease Related-Dementias (ADRD). These and other noninheritable factors are collectively known as the exposome and includes environmental stress which is a major factor in racial and ethnic health inequities. ADRD is more prevalent and severe in people who live in lower resourced environments, and there is a need to identify the most important risk factors and determine their mechanistic underpinnings. n/a AD/ADRD
2023/05 HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain Mary Ann Pelleymounter This concept aims to address issues surrounding the unmet medical need for effective pain medications by facilitating the development of safe, effective, and non-addictive small molecule and biologic therapeutics through the HEAL Pain Therapeutics Development Program (PTDP). The concept aims to support optimization and initial clinical testing of pain therapeutic candidates. n/a HEAL
2023/02 Blueprint ENDURE Michelle Jones-London The over-arching goal of this NIH Blueprint concept is to encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical, behavioral, and clinical research workforce, to pursue further studies or careers in neuroscience research. To accomplish the stated over-arching goal, this concept may support creative educational activities with a primary focus on Courses for Skills Development, Research Experiences, and Mentoring Activities. The fully integrated educational activities should prepare undergraduate students from diverse backgrounds, including those from groups underrepresented in biomedical and behavioral sciences to enter Ph.D. degree programs in the neurosciences. To accomplish this goal, this concept may provide institutional awards to develop neuroscience research education programs comprised of collaborative partnerships integrated across different educational institution types. n/a
2023/02 ME/CFS Collaborative Research Centers (CRCs) Vicky Whittemore This concept aims to support collaborative research centers (CRCs) performing research focused on understanding the cause(s) of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), identifying potential therapeutic targets and supporting basic experimental studies involving human subjects (BESH) studies on ME/CFS. Applications may include a cohort of individuals with post-acute sequelae SARS-CoV-2 infection (PASC) (i.e., Long COVID), as long as ME/CFS is the focus of the application. The continuation of the CRCs could allow continued expansion of the research on ME/CFS and allow for increased collaboration across the Centers and with other investigators in the field. In addition, this concept aims to support CRCs advancing from basic research on ME/CFS to translational studies. Presentation and Discussion - Vicky Whittemore begins at 4:17:00 and ends at 4:21:00
2023/02 NINDS Exploratory Grant Program in Parkinson's Disease Research Beth-Anne Sieber The goal of this concept is to provide time and resources required to formalize collaborations, collect preliminary data, establish administrative infrastructure, and establish a foundation for Parkinson’s Disease (PD) research discovery leading to a competitive application for an NINDS Morris K. Udall Center of Excellence for PD Research. n/a
2023/02 Morris K. Udall Centers of Excellence for Parkinson's Disease Research Beth-Anne Sieber This concept proposes continuation of the NINDS Morris K. Udall Centers of Excellence for Parkinson’s Disease (PD) Research program by providing support for innovative, interdisciplinary teams to meet a defined PD research challenge, as well as to serve as national leaders who share resources and knowledge, foster the next generation of PD researchers, and develop proactive outreach approaches for the local patient and advocacy community. n/a
2023/02 Institutional Translational Research Training Program Stephen Korn The goal of this concept is to equip trainees with the knowledge and skills needed to advance basic research toward clinical application. Furthermore, the concept will support students and/or postdocs conducting basic, disease-relevant research in an environment that includes 1) basic scientists and clinicians who are actively engaged in collaborative research projects, 2) neuroscience researchers with expertise in translational processes who are conducting research designed to move basic discoveries toward clinical application and 3) relationships with industry and government regulatory agencies. n/a
2023/02 NINDS Postdoctoral Mentored Career Development Award Stephen Korn This concept aims to support the ability of outstanding, mentored postdoctoral researchers to develop a potentially impactful research project, which will form the basis of a future independent research program. Furthermore, the concept will provide an opportunity for postdoctoral fellows who are still early on in their training to develop outstanding research projects in areas that will advance the goals of the NINDS mission and gain the experience needed for the successful transition to an independent research career. n/a
2023/02 Emergency Medicine Research Career Development Program Stephen Korn This concept aims 1) to provide the training, research experience, and mentorship needed for outstanding junior Emergency Medicine (EM) physicians selected from a national applicant cohort to obtain K awards and 2) to develop a national clinician-scientist community within the EM specialty that will foster both growth and maintenance of a strong, NIH-funded research contribution by EM physicians. Research (especially clinical research) into, for example, seizures, head trauma, acute cognitive dysfunction, acute stroke, sensory loss, loss of consciousness, spinal cord injury, meningitis, and many other neurological disorders can benefit significantly from the leadership and involvement of EM physicians. Presentation and Discussion - Steve Korn begins at 4:25:00 and ends at 4:40:00
2023/02 NINDS Sustainable Transformation of Institutional Research Rigor (STIRR) Program Devon Crawford This goal of this concept is to support establishing programs to enhance research rigor and transparency practices within academic and research institutions to promote high-quality neuroscience research. Attention to principles of good study design and transparent reporting are essential to enable the neuroscientific community, as well as the biomedical community at large, to design and perform valid experiments and to assess the value of scientific findings. This concept could support implementing innovative programs, strategies, and approaches to promote a culture of research quality at the departmental, inter-departmental, or equivalent entity level. Presentation and Discussion - Devon Crawford begins at 3:47:30 and ends at 4:17:00
2023/02 Recompeting of Existing NIH Blueprint Neurotherapeutics Network Chuck Cywin This concept aims to support the NIH Blueprint Neurotherapeutics Network (BPN), which has active research projects that are expected to continue through 2030. BPN supports therapeutics development on behalf of 12 institutes and centers across NIH using cooperative agreements. The concept will continue support current contracts that are set to expire sequentially over the next few years. These contracts are for 1) Phase I clinical trials, 2) drug manufacturing and formulation, 3) pharmacokinetics and toxicology, 4) collaborative drug discovery relational database, and 5) medicinal chemistry. The contracts scopes are expected to remain the same in all cases fundamentally. n/a
2023/02 NIH Countermeasures Against Chemical Threats (CounterACT): Translational Exploratory/ Developmental Research Projects Shardell Spriggs The goal of this concept is to support exploratory translational research that directly advances the discovery of novel treatment strategies for medical countermeasures (MCMs), that address serious morbidity and mortality after acute exposure to highly toxic chemical threats. Projects are expected to generate preliminary data that would facilitate the development of competitive applications for more extensive support from the NIH CounterACT Cooperative Agreement program and/or other related initiatives. n/a
2023/02 Understanding Neurological Effects of COVID-19 and Post-Acute Sequelae of SARS-CoV-2 Infection Lumy Sawaki-Adams The goal of this concept is to support research projects focusing on the mechanisms, biomarkers, pathophysiology, prevention, and/or treatment of neurological manifestations of COVID-19 and Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). Furthermore, this concept will support projects that propose scientifically compelling pathways to prevent the development of PASC or to accelerate the development of effective treatments for PASC-related neurological complications. Overall, research projects supported by this concept might bridge the gaps in research focused on neurological/neuropsychiatric aspects of the pandemic. Presentation and Discussion - Lumy Sawaki-Adams begins at 4:21:00 and ends at 4:25:00
2023/02 Blood Brain Barrier Response to Antibodies Targeting Beta-Amyloid Rod Corriveau The goal of this concept is to support the discovery of cellular and molecular mechanisms that underlie brain blood vessels' responses to passive anti-beta-amyloid immunotherapy used in the treatment of mild cognitive impairment and mild dementia stages of Alzheimer's Disease (AD). The response of blood vessels can compromise blood-brain barrier (BBB) integrity, and if the response increases, it can ultimately result in amyloid-related imaging abnormalities (ARIA). This concept aims to establish an understanding of molecular mechanisms that can be targeted to protect the BBB, and thus the brain blood vessels, during therapeutic interventions targeting beta-amyloid. n/a AD/ADRD
2023/02 Early-Stage Therapy Development for ADRD Becky Roof This goal of this concept is to encourage early-stage development of novel small molecules or biologic therapeutics for Alzheimer's Disease-Related Dementias (ADRD). This includes 1) development of in vitro and/or ex vivo assays that can support therapeutic screening efforts, 2) screening efforts to identify and characterize potential therapeutic agents, 3) therapeutic optimization, pharmacodynamic and pharmacokinetic studies, and 4) in vivo efficacy studies in an animal model of disease. n/a AD/ADRD
2023/02 Genome Editing for ADRD Tim LaVaute The goal of this concept is to support early translational research focused on somatic cell genome editing for Alzheimer's Disease Related Dementias (ADRDs). The emergence of CRISPR (clustered regularly interspaced short palindromic repeats) based in vivo genome editing approaches holds significant potential for developing therapeutic options for a broad range of ADRD patients with either disease-causing or risk-gene etiology of ADRD. These studies may be able to address the feasibility of using genome editing for therapy development for ADRDs. n/a AD/ADRD
2023/02 PET ligand development for the ADRDs Deb Babcock The goal of this concept is to support a multi-center program that will apply innovative and interdisciplinary approaches to identify and validate Positron Emission Tomography (PET) radioligands for Alzheimer's Disease Related Dementias (AD/ADRD)-related targets and pathways. PET ligands for AD/ADRD have been tremendously important for establishing disease diagnosis, progression and, with the recent development of antibody-based therapies, play an essential role in treatment decisions. This concept will encourage collaborations with investigators overseeing brain bank resources and/or those managing existing ADRD-related resources and clinical infrastructure. n/a AD/ADRD
2023/02 Development & Characterization of Experimental models of post-TBI ADRD Hibah Awwad This concept aims to support interdisciplinary teams focused on developing and characterizing a variety of experimental models that can accurately reproduce the neuropathological signatures and clinically relevant neurodegenerative, biochemical, and behavioral traumatic brain injury (TBI)-related dementia phenotypes in humans. Successful models will accelerate the identification of factors and mechanistic pathways contributing to the predisposition, initiation of, and development of neurodegenerative dementia post-TBI. n/a AD/ADRD
2023/02 Development and Validation of Models for ADRD Linda McGavern AND Becky Roof This concept aims to support the development and validation of clinically relevant models of Alzheimer’s Disease Related Dementias (ADRD). Cellular and animal models of multiple interacting pathologies, that mimic the risk factors and comorbidities seen in patients, and that advance key molecular pathways in a pathophysiologically relevant context will be supported. New models need to be innovative and address a gap in the currently available models. n/a AD/ADRD
2023/02 Investigating Distinct and Overlapping Mechanisms in TDP-43 Proteinopathies, including in LATE, FTD, and other ADRDs Linda McGavern This concept aims to support studies establishing a deeper mechanistic insight and cellular and molecular relationships between TDP-43 pathology and clinical phenotypic outcomes. Research could require comparisons between Alzheimer’s Disease Related Dementias (ADRD) TDP-43 proteinopathies, such as limbic-predominant age-related TDP-43 encephalopathy (LATE), with or without Alzheimer’s disease neuropathologic change (AD-NC), and frontotemporal lobar degeneration with TDP-43 inclusions (FTLD-TDP) to further understand distinct and overlapping mechanisms in these syndromes. n/a AD/ADRD
2023/02 Mechanistic Investigations into ADRD Multiple Etiology Dementias Linda McGavern The goal of this concept is to support investigations with a minimum of two relevant Alzheimer’s Disease Related Dementias (ADRD) co-pathologies (e.g., tau, alpha-synuclein, TDP-43, TMEM106B, vascular) to identify interactions and cellular and molecular mechanisms upstream of aggregated protein states and to determine how these early interactive multi-pathology mechanisms drive worsening neurodegenerative processes and clinical phenotypic outcomes. n/a AD/ADRD
2023/02 Multi-Target Validation for ADRD Becky Roof The majority of efforts to develop therapies for Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD) focus on individual drugs developed against a single target; however, ADRDs involve multiple pathways and pathologies. The goal of this concept is to validate multiple targets for future therapy development for ADRDs that better reflect the complexity of the disease. n/a AD/ADRD
2023/02 Neuropathological Interactions Between COVID-19 and ADRD Will Daley This concept aims to support studies in animal, cell culture, and/or human tissue models to elucidate the mechanisms by which COVID-19 interacts with and/or modulates Alzheimer’s Disease Related Dementias (ADRD)-relevant phenotypes. Either the model itself or the experimental readouts may be required to incorporate ADRD risk factors, pathologies, or relevant comorbidities. n/a AD/ADRD
2023/02 Development and validation of remote or patient wearable device derived objective biosignatures or functional assessments to monitor pain for use as endpoints in clinical trials Ram Arudchandran The goal of this concept is to enable the development and validation of real-world remote digital endpoints from wearable devices for monitoring pain experience and progression, response to interventions, and impact on quality of life. Endpoints could include biosignatures derived from functional and physiological assessments detected from wearable devices. These biosignatures can be used to monitor the effects of therapeutics developed for the treatment of pain. n/a HEAL
2023/02 Exposome Factors that Influence Pain Severity, Persistence and Resilience after Surgery David Jett The exposome describes the totality of internal and external exposures that affect human health.  There are several exposomic factors associated with pain, such as microbiome and biopsychosocial influence. This concept aims to support research on the influence of the exposome on pain severity, persistence, and resilience after surgery.  Studies would focus on the factors that determine whether a person does well or does poorly in pain severity and will develop exposomic phenotypes of patients that undergo surgery. n/a HEAL
2023/02 Mechanistic Studies on the Effect of the Exposome on Acute and Chronic Pain David Jett The exposome describes the totality of internal and external exposures that affect human health.  Studies in humans have identified some exposomic factors that influence pain severity and tolerance, including microbiome, drugs and alcohol, sleep alteration, stress, and other biopsychosocial effects.  The goal of this concept is to support mechanistic research to study how the exposome interacts with known and new molecular targets that affect pain. n/a HEAL
2023/02 Understanding Individual Differences in Human Pain Conditions DP Mohapatra This concept aims to support research towards a holistic understanding of individual differences in human pain conditions that would put the focus on ‘Whole Person Health’ and contribute to enhancing pain treatment and management strategies for personalized pain medicine. Research in this area will address inter-individual differences in pain perception, pain severity, HEAL core pain domains, treatment responsiveness, and the impact of comorbidities. This research will address a critical gap in the NIH HEAL Initiative pain portfolios, address a programmatic need to understand the biological underpinnings of pain heterogeneity and individual differences towards patient stratification through rigorous data-driven and evidence-based approaches, and in the long-term will move us closer to precision pain medicine. n/a HEAL
2023/02 Interdisciplinary Clinical Pain Research Institutional Training Grant Laura.Wandner@nih.gov There is a great need to ensure a diverse pool of highly trained scientists is available to expand and enhance the clinical pain research workforce. This concept aims to provide support for 4 clinical post-doctoral programs, facilitate networking among award recipients, and provide a cohort experience for trainees by supplementing the HEAL R24 Center. n/a HEAL
2023/02 BRAIN Initiative: Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain Jim Gnadt Investigations within the human brain offer revolutionary, but challenging, opportunities for experimental investigation of how the human brain senses, perceives, remembers, plans, registers emotions, activates movements, and makes decisions. Invasive surgical procedures offer the opportunity for unique intracranial interventions. However, human studies using invasive technology are often constrained by a limited number of patients and resources. This concept aims to assemble diverse, integrated, multi-disciplinary teams to investigate these high-impact questions in human neuroscience. n/a BRAIN
2022/10 Sudden Death in Young Registry Vicky Whittemore This concept would be a continued collaboration project between NINDS, the National Heart, Lung, and Blood Institute (NHLBI), the Centers for Disease Control and Prevention (CDC), and public health offices across the U.S. One of the goals is to compile information from Sudden Death in the Young (SDY) cases to create a resource of clinical data and biospecimens for research into the causes of SDY. NINDS is interested in obtaining data and resources for the registry from sudden unexpected deaths in epilepsy (SUDEP) and other neurological causes of SDY. The SDY data to date have provided a better understanding of the incidence and causes of SUDEP in children in the U.S. Furthermore, the ability to collect tissue biospecimens from SUDEP individuals may aid research to understand the cause(s) and identify ways to prevent SUDEP. Presentation and Discussion - Vicky Whittemore begins at 2:59:00 and ends at 3:06:00
2022/10 NIH Blueprint for Neuroscience Research - Joint resources for human single-cell omics data from BRAIN and Blueprint ICs Daniel Miller This concept aims to harmonize single-cell omics data from human brain tissue across NIH Initiatives and Blueprint Institutes/Centers (ICs) into datasets that use common data standards and are accessible from joint sharing platforms. The concept aims to encourage cross-disease and cross-consortia analysis by leveraging NIH BRAIN Initiative reference data as common control data for IC-generated disease data, pilot infrastructure for coordinated access to IC-supported and BRAIN-generated human data and potentially provide the groundwork for substantial resources across brain disease states. Presentation and Discussion - Daniel Miller begins at 3:06:00 and ends at 3:16:00
2022/10 NIH Neuroscience Development for Advancing the Careers of a Diverse Research Workforce Marguerite Matthews This concept aims to foster programs that improve underrepresented neuroscientists' professional development and networking through creative and innovative research/educational projects. This could include, but may not be limited to, support programs that provide career advancement opportunities for underrepresented graduate students, postdoctoral researchers, and early career investigators. In addition, this initiative may support creative educational activities with a primary focus on NINDS-relevant research experiences, mentoring activities that enhance competencies or leadership education, and courses on skills development. Altogether, this initiative aims to aid in increasing workforce diversity and encourage growth in the areas of neuroscience. Presentation and Discussion - Marguerite Matthews begins at 2:51:00 and ends at 2:59:00
2022/10 ClinGen Genomic Expert Curation Panels Vicky Whittemore This concept aims to support panels of subject matter experts who could evaluate the clinical applications of gene-disease relationships and the pathogenicity of individual genetic variants in neurological and neuromuscular diseases. Knowledge of genetic-associated conditions could provide critical information that is used in research to understand the functional significance of these diseases and the development of new targeted treatments, as well as to assist health care providers in the diagnosis and clinical care of individuals with the genetic diseases. n/a
2022/10 Jointly Sponsored Ruth L. Kirschstein National Research Service Award Institutional Predoctoral Training Program in the Neurosciences Delany Torres-Salazar The Jointly Sponsored Predoctoral Training Program in the Neurosciences (JSPTPN) aims to provide outstanding graduate students with vital, broad training in neuroscience, emphasizing quantitative skills. The goal is to provide trainees with the motivation and means to become future leaders in their fields and give them tools for success as they progress in their careers. This could include skills that help trainees to excel in various sectors, including but not limited to research-intensive careers in academia, industry, or research-supported careers in various sectors. In addition, this could assist in providing fellows with access to career development advising and other learning opportunities, and obtain imperative knowledge to transition successfully into the next stage of their chosen career. n/a
2022/10 BRAIN Initiative: Biology and Biophysics of Neural Stimulation and Recording Technologies Nick Langhals This concept aims to understand how technologies that stimulate and record from cells in the Central Nervous System (CNS) work. Some projects may characterize, validate or model the neurobiological, cellular and circuit responses to stimulation of cells. Other projects may investigate the biological and bioinformatic content of signals recorded from neuronal and non-neuronal cells and circuits. This obtained knowledge, in turn, could help develop and improve technologies for stimulating and recording cells and circuits in the CNS. The knowledge received from these goals aligns with the missions of both the NIH BRAIN Initiative and of NINDS. n/a
2022/05 HEAL Initiative: Development and Validation of Non-Rodent Mammalian Models of Pain HEALAnimalModels@nih.gov This initiative aims to support the development and rigorous validation of non-rodent mammalian models of pain, associated outcome measures and/or endpoints that enhance translational research for effective pain management. These models are expected to recapitulate molecular, cellular, pathological, behavioral, and/or cognitive aspects of human pain disorders and conditions. Research supported under this FOA is expected to provide well-validated models and measures that facilitate the development of non-opioid analgesic therapeutic interventions. Presentation and Discussion - HEAL Initiative begins at 2:50:00 and ends at 3:01:30 HEAL
2022/05 HEAL Initiative: Integrated Basic and Clinical Team-based Research in Pain DP Mohapatra The goal of this proposed concept is to support integrated research efforts for pursuing bold, impactful, and challenging research to understand the biology of specific human pain conditions as well as pain associated with diverse diseases/disorders. The concept would promote collaborative work across the continuum of basic to clinical research to allow for comprehensive, interdisciplinary, and mechanistic research in efforts to pursue ambitious solutions for basic, translational, and clinical research questions in human pain within the mission of the NIH HEAL Initiative. Presentation and Discussion - DP Mohapatra begins at 2:50:00 and ends at 3:01:30 HEAL
2022/05 HEAL Business Development and Embedded Entrepreneur Supplements for Small Businesses in Pain Management  Emily Caporello This planned concept is intended to support business development activities and the addition of business management expertise in SBIR- and STTR-funded small businesses working in the pain space. The program is intended to support HEAL goals of advancing novel pain therapies and technologies to the market by addressing business development gaps experienced by many small businesses including those working in pain. Presentation and Discussion - Emily Caporello begins at 2:50:00 and ends at 3:01:30 HEAL
2022/05 HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management  Emily Caporello This concept aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Technology Transfer (STTR) and Small Business Innovation Research (SBIR) programs. n/a HEAL
2022/05 HEAL Initiative: Interdisciplinary Team Science to Uncover the Mechanisms of Pain Relief by Medical Devices Eric Hudak The initiative aims to support interdisciplinary research teams to utilize multi-faceted approaches to discovering the mechanisms of pain relief by FDA-approved or cleared medical devices. This initiative also aims to identify physiological markers of pain relief and determine how therapeutic approaches affect them to optimize therapeutic outcomes for device-based treatments. n/a HEAL
2022/05 HEAL Initiative Contract: Preclinical Screening Platform for Pain: Renewal and Recompete Contract for Award in 2024  Smriti Iyengar The goal of this program is to accelerate the discovery and development of non-opioid, non-addictive treatment for pain. The program will award a 5-year contract to evaluate and accelerate preclinical development of novel therapeutic approaches and is open to industry, academic institutions, and government organizations. The program aims to provide a comprehensive, centralized preclinical screening platform for evaluating small molecules, biologics, natural products, and devices for their potential as non-opioid, non-addictive treatments for pain. Presentation and Discussion - Smriti Iyengar begins at 2:50:00 and ends at 3:01:30 HEAL
2022/05 CounterACT: Basic and Early Translational Research on Chemical Threats Shardell Spriggs This goal of this planned concept is to serve as a fundamental research basis for the NIH CounterACT program and would be the only initiative at NIH to study mechanisms of toxicity for the chemical threats assigned to NINDS. These include nerve agents and other agents that target the nervous system, as well as cyanide, anticoagulants and other agents not covered by the other CounterACT IC-led efforts. It would align with the overarching goals of the NIH CounterACT program, which are to understand the fundamental mechanisms of toxicity caused by chemical threat agents and to support research and development of therapeutics. It is similar to other new CounterACT IC-led initiatives that engage more research and researchers within their mission space. This initiative would also serve as a pipeline to the NIH CounterACT translational and cooperative agreement programs and provides investigators with a pathway to develop competitive submission packages for future grant applications. n/a
2022/05 Extracellular RNA Sequencing Research Resource for the AMP PD Deb Babcock The goal of this proposal is to provide a comprehensive research resource of longitudinal, extracellular vesicle (EV)-derived RNA sequencing data. This resource would include EV-derived sequencing data from subjects with Parkinson's disease (as well as healthy controls) who currently have whole genomic, transcriptomic, and proteomic sequencing data available on the Accelerating Medicines Partnerships Parkinson's Disease (AMP PD) Knowledge Platform. This program aims to accelerate progress in understanding EV trafficking and research into extracellular RNA’s potential use as a biomarker for neurological disorders. n/a
2022/05 Increasing diverse and neurotypical brain donation Daniel Miller This planned concept has several main goals related to the NeuroBioBank's mission to coordinate the collection of high-quality human brain tissue for broad and democratic sharing. Specifically, this concept aims to raise awareness of the importance of post-mortem brain donation among underrepresented groups and to identify barriers among these groups to brain donation. Additionally, this concept aims to increase preregistrations for brain donation from members of underrepresented communities, as well as increase collections from neurotypical and diverse brains by strengthening collaborations between post-mortem tissue collection sites. Presentation and Discussion - Daniel Miller begins at 3:12:45 and ends at 3:27:45
2022/05 NIDA, NIMH, and NINDS Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity Michelle Jones-London This proposed concept is intended to support new investigators and At-Risk Investigators from diverse backgrounds, including those from underrepresented groups in the health-related sciences. This program would be in line with the NINDS's mission to ensure a vibrant, talented, and diverse workforce and is consistent with the provisions of the 21st Century Cures Act as well as the recommendations from the NIH Advisory Council to the Director. n/a
2022/05 Early Stage and Established Biomedical Data Repositories (DR) or Knowledgebases (KB) Lindsey Scott The goal of this concept is to fund sustainable data repositories and knowledgebases that deliver scientific impact, employ and promote good and efficient data management, engage the user community, and govern to address data life-cycle, long-term preservation, and trust-worthiness. This concept would support efforts to develop accessible, well-maintained, and efficiently operated data resources with good data management practices, as outlined by the FAIR (Findable, Accessible, Interoperable, and Reusable digital objects) Data Principles. n/a
2022/05 BRAIN Initiative Advanced Postdoctoral Career Transition Award (K99/R00) Ned Talley This proposed concept aims to enhance diversity in the neuroscience workforce and maintain a strong cohort of new and talented, NIH-supported, independent investigators from diverse backgrounds in BRAIN Initiative research areas. This would be achieved by providing outstanding postdoctoral researchers with independent NIH research support and training using cutting-edge tools, theories and/or approaches. This will facilitate a timely transition into competitive, independent research careers in areas that will advance the goals of the BRAIN initiative. n/a BRAIN
2022/05 BRAIN Initiative: Optimization of Transformative Hardware and Device Technologies Ned Talley This planned concept aims to optimize existing and emerging technologies and approaches that have potential to address major challenges in recording and stimulating neural activity in any region of the brain. This concept is intended to support the refinement of emergent technologies and approaches that have already demonstrated their transformative potential through proof-of-concept testing. These technologies and approaches should be appropriate for accelerated development of hardware and software while scaling manufacturing towards sustainable, broad dissemination and user-friendly incorporation into regular neuroscience practice. n/a BRAIN
2022/02 NIH Countermeasures Against Chemical Threats (CounterACT) Discovery and Early-stage Therapeutic Development Research David Jett The goal of this concept is to support translational research on developing therapeutics for treating morbidity and mortality after exposure to highly toxic chemical threats. The NIH CounterACT research program manages a large portfolio of medical countermeasure (MCM) projects that includes priority chemical agents as determined by the Department of Homeland Security (DHS). This concept would allow for cooperative agreements between investigators and NIH Program staff and an accelerated transition from early studies to candidate readiness for advanced development. n/a
2022/02 NINDS Interdisciplinary Team Science Karen David This concept is designed to support integrated efforts of three or more (up to six) PDs/PIs to pursue bold, impactful, and challenging research in any area within the scope of the NINDS mission. The research approach expected should be interdisciplinary in nature, and the research teams would be expected to establish a common goal that requires collaboration, synergy, and managed team interactions. Presentation and Discussion - Karen David begins at 3:44:15 and ends at 4:02:47
2022/02 NIH Countermeasures Against Chemical Threats (CounterACT) Early-stage Investigator Research Award David Jett The goal of this concept is to recruit and establish early-stage investigators (ESIs) into the chemical countermeasures research field with peer-reviewed awards. This proposal would provide extended time and support to enable funded ESIs the ability to generate sufficient preliminary data to competitively apply for CounterACT cooperative agreement funding opportunities. Applicants that successfully compete for these awards would not lose their ESI status. This concept would be a planned reissue of PAR-21-209. n/a
2022/02 Research Program Award (R35 Clinical Trial Optional) R35 Outstanding Investigator Award Alisa Schaefer The purpose of the NINDS Research Program Award (RPA) would be to provide longer-term support and increased freedom and flexibility to Program Directors (PDs)/Principal Investigators (PIs), allowing them to redirect their time away from the administrative burden of writing and managing multiple grant applications and towards engaging in the lab. This concept would be a planned reissue of RFA-NS-21-020. n/a
2022/02 Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases Glen Nuckolls This initiative invites researchers to submit applications for support of clinical studies that address critical needs for clinical trial readiness in rare neurological and neuromuscular diseases. This program supports multi-site, prospective, longitudinal studies aimed at clinical validation of outcome assessment measures and biomarkers to enhance the design and increase the likelihood of success of upcoming clinical trials. This concept would be a planned reissue of PAR-19-220. n/a
2022/02 Education Program on Translational Devices Kari Ashmont This planned concept would support course development to train investigators and entrepreneurs to successfully translate and commercialize medical devices - critical tools that help to reduce the burden of neurological disease. It draws on lessons learned in academia and industry to create a comprehensive program aimed at filling the translational and commercialization knowledge gaps for the academic investigator and small business communities. This concept would be a planned reissue of RFA-NS-20-003. n/a
2022/02 NINDS Stroke Trials Network (StrokeNet) network Infrastructure Scott Janis The primary goal of the NINDS Stroke Trials Network (NIH StrokeNet) is to develop, promote and conduct high-quality, multi-site clinical trials focused on key interventions for stroke prevention, treatment, and recovery. This concept aims to extend support of the current infrastructure of the network, including the National Clinical Coordinating Center, the National Data Management Coordinating Center, and the Regional Coordinating Centers and with their network of clinical sites that will support the continued activities in the network. n/a
2022/02 Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT) The purpose of the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT) is to provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. This concept aims to support a clinical research network that will develop and conduct multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies, whether from academic, foundation or industry discoveries. n/a
2021/10 HEAL Pathway to Independence Award in Pain and SUD Research DP Mohapatra This aim of this concept is to increase the independent investigator workforce in research areas supported by the NIH HEAL Initiative, by facilitating a timely transition of outstanding postdoctoral researchers from mentored research positions to independent, tenure-track or equivalent faculty positions. The program would provide independent NIH research support during this transition to help awardees to launch competitive, independent research careers in research areas supported by the NIH HEAL Initiative. Furthermore, this concept also seeks to enhance biomedical research workforce diversity of independent investigators in research areas supported by the NIH HEAL Initiative. Presentation and Discussion - DP Mohapatra begins at 3:19:50 and ends at 3:41:37 HEAL
2021/10 HEAL Advancing Health Equity in Pain and Comorbidities Cheryse Sankar The goal of this proposal is to expand on the HEAL Initiative's efforts to advance health equity. Specifically, this proposal aims to develop, test, and implement novel, multi-level, culturally appropriate interventions and/or adapt, test and evaluate efficacy and effectiveness of existing interventions in NIH designated populations that disproportionately experience negative health outcomes (HDPs). Interventions that target HDPs with chronic pain in addition to at least one comorbid condition (OUD, mental health disorders and/or chronic health conditions) are of the highest priority. Presentation and Discussion - Cheryse Sankar begins at 3:19:50 and ends at 3:41:37 HEAL
2021/10 HEAL Enhancing the Clinical Pain Management Workforce Initiative Linda Porter One goal of this proposed concept is to promote the expansion and enhancement of a diverse workforce of highly trained scientists in the area of clinical pain research through a nation-wide mentoring and networking program. It will provide mentoring and skills necessary to support practitioners who seek a career in clinical pain management research. Another goal is to create an environment where early-stage clinical pain researchers can connect and collaborate with early and experienced basic and translational researchers through a centralized network and sponsored events. The concept would promote collaborative research across the continuum of basic to clinical research to ensure that research outcomes are meaningful to people who suffer with acute or chronic pain. Presentation and Discussion - Linda Porter begins at 3:19:50 and ends at 3:41:37 HEAL
2021/10 HEAL: Coordinated Pain Care in Health Care Systems Linda Porter There is a pressing need for access to coordinated pain management for people with chronic pain, especially those with other chronic health conditions. Pain care often is delivered as a single intervention such as medication or injections, through one setting, and by a single health care provider. This approach often results in inadequate pain relief and poor health outcomes. This proposed concept would support research projects to embed effective coordinated pain care into health care systems. The coordinated care strategy could be centered in primary care settings with an integrated referral system to specialty care or could be centered in specialty care programs and coordinated with primary care. A coordinating center would support the development and implementation of the research projects, ensure collaboration across the project teams, provide regulatory support, and promote adoption of effective coordinated models of pain care in health care systems. Presentation and Discussion - Linda Porter begins at 3:19:50 and ends at 3:41:37 HEAL
2021/10 Next Generation HEAL Biomarker Program: Translational Tools to Facilitate Clinical Trials for Pain Therapeutics Ram Arudchandran Pain therapeutics development has been hampered by a dearth of specific and sensitive biological signatures or clinical measures that predict and/or monitor response to therapy. By supporting mechanistic research that is directed toward the development, validation, and implementation of a biological signature or clinical measure of pain, this concept aims to develop a toolkit of measures that will facilitate Phase II clinical trials for pain therapeutics or improve treatment decisions in pain management. Presentation and Discussion - Ram Arudchandran begins at 3:19:50 and ends at 3:41:37 HEAL
2021/10 Clinical Trial Readiness for Functional Neurological Disorders This proposed concept aims to address the lack of available standardized outcome measures to enhance clinical trial readiness across Functional Neurological Disorders (FNDs). Successful applications would result in fit-for-purpose validation of biomarkers, endpoints, and clinical outcome assessments that can be directly applicable for planned FND clinical trials and the collection of high-level evidence. Presentation and Discussion - Codrin Lungu begins at 4:18:10
2021/10 Identification of Clinical Outcome Assessments to Measure Efficacy through Natural History Studies of Ultra-Rare Neurological and Neuromuscular Diseases Jill Morris The goal of this proposed concept is to support both retrospective and prospective natural history studies of individuals with ultra-rare neurological diseases to identify and evaluate the utility of clinical outcome assessments (COAs). In turn, COAs could be used to determine efficacy in clinical trials and remove major barriers to therapy development. This concept would be aimed specifically towards ultra-rare disorders with therapies being actively developed with an expectation of clinical trials in the near future. Presentation and Discussion - Jill Morris begins at 4:24:20
2021/10 NINDS Doctoral Readiness (DR.) Program Michelle Jones-London This concept seeks to diversify the pool of well-trained post-baccalaureates who plan to pursue scientifically rigorous neuroscience research-focused Ph.D. programs. This would be achieved by creating a pilot program to bridge the critical career stage gap between college and graduate school for individuals with little to no access to rigorous research opportunities. Importantly, this proposed concept aims to examine the impact of a well-structured, two-year research experience at an institution with an outstanding graduate training environment on preparedness and candidacy for neuroscience doctoral programs. Presentation and Discussion - Michelle Jones-London begins at 4:30:18
2021/10 NeuroBioBank (NBB) Communications and Outreach Initiative Daniel Miller The goal of this proposed concept is to strengthen communication and outreach of the NIH Neurobiobank (NBB), to better provide the scientific research community with high quality human brain tissues. Through an open competition, an organization will be selected to meet the need for a coordinated communications strategy within the multi-site structure of the NBB. This will enable harmonized messaging and increased efficiency in outreach and public education about the importance of human brain donation. Presentation and Discussion - Daniel Miller begins at 4:43:40
2021/10 CDE/Monitoring/Data Archive Contract Recompetition Carolina Mendoza-Puccini This concept supports an open competition for a five-year contract covering four areas: the monitoring of NINDS intramural clinical trials, data archiving, statistical support, and development and maintenance of the NINDS Common Data Elements (CDEs) project. Use of the CDEs helps to improve data accuracy, consistency, and interoperability among datasets, and have been integrated in data science strategic plans for NIH and NINDS. The proposed solicitation is for a recompetition of the NINDS Center for Clinical Trials Resources (CCTR). n/a
2021/10 Stroke Preclinical Assessment Network (SPAN) Francesca Bosetti The Stroke Pre-Clinical Assessment Network (SPAN) utilizes a novel, adaptive, secured system and a multi-site approach for parallel testing of promising cerebrovascular protective interventions designed to extend the treatment time window and/or improve outcome when combined with thrombolysis, thrombectomy or both in acute ischemic stroke. We propose the continuation of the network's activities (SPAN-Next) to screen and select highly promising treatment candidates for possible further study in human clinical trials. This concept would be a planned reissue of RFAs NS-18-033 and NS-18-034. n/a
2021/10 BRAIN Initiative: Research Resources Grants for Technology Integration and Dissemination U24 Natalie Trzcinski The overall goal of this concept is to accelerate the scientific impact of the NIH BRAIN Initiative through rapid dissemination of developed and validated technologies and resources broadly to the neuroscience research community. This initiative would provide up to five years of support to projects that are highly relevant to the NIH BRAIN Initiative, disseminating resources for integration into neuroscience research practice and would be a proposed reissue of RFA-NS-19-006 . n/a BRAIN
2021/10 Prospective Observational Comparative Effectiveness Research in clinical Neurosciences Adam Hartman Given the high cost of traditional randomized controlled trials (RCTs) and their potential limitations, other approaches to developing rigorous evidence to support clinical decision-making are needed. One example of this approach is the prospective observational comparative effectiveness study (CER): the conduct of research comparing the benefits and harms of different existing interventions and strategies to prevent, diagnose, treat and monitor health conditions in "real world" settings. This concept is a planned reissue of PAR-19-171. n/a
2021/10 Data Harmonization, Curation, and Secondary Analysis of Exsting Clinical Datasets Christine Swanson-Fischer This proposed concept would support interdisciplinary teams to curate, harmonize, and propose innovative, hypothesis-driven methods for performing secondary data analyses of existing multi-site clinical research datasets within the NINDS mission. Consistent with the FAIR (findable, accessible, interoperable and reusable) data principles, all awardees must make the datasets and associated processes and tools widely available to the scientific research community. This concept would be a planned reissue of RFA-NS-20-007. n/a
2021/10 Small Vessel VCID Biomarker Validation Consortium Coodinating Center (U24) Rod Corriveau The overall goal of this concept is to deliver high-quality biomarkers ready for use in clinical trials, and for generating scientific breakthroughs in our understanding and treatment of vascular contributions to cognitive impairment and dementia (VCID). This proposed funding opportunity would support a coordinating center for the NINDS small vessel VCID biomarkers consortium that was established in 2016 under NS-16-019 and NS-16-020. n/a
2021/10 Development of Biomarkers or Biomarkers Signatures for Neurological & Neuromuscular Disorders Carol Taylor-Burds The goal of this proposed funding opportunity is to enable the development of biomarkers or biomarker signatures ready for definitive analytical and clinical validation, as research tools for therapeutic development or for informing clinical practice. This would be a planned reissue of PAR-19-315. n/a