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SHARE: 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.


  File
              This is a preview of the Data Table. Only the first three rows are displayed.
    
    
          ﻿Council Round
                                                                              Concept Title
                                                                              Point of Contact
                                                                              Description
                                                                              Link to Council Discussion
                                                                              Category2023/09
                                                              Research Grant for Junior Faculty Clinician-Scientists
                                                              Tish Weigand
                                                              This concept aims to provide a means for early-career non-citizen (non-permanent resident) clinicians at the fellowship/junior faculty stage to gain the necessary financial support and research experience to be competitive for NIH research grants. A relatively large number of clinician fellows obtain their medical training abroad but come to the US and are ineligible for NIH career development awards, resulting in a loss of research talent for the biomedical workforce. This concept’s overarching goal is to allow such fellows to develop their expertise and a research project suitable for growing an independent research career.
                                                              Presentation and Discussion - Steve Korn begins at 4:31 and ends at 4:462023/09
                                                              NINDS Research Education Opportunities
                                                              Tish Weigand
                                                              This concept aims to support a small number of exceptional research education programs with national reach. Supported programs would be taught by nationally or internationally recognized scientists and would provide hands-on experiences that offer state-of-the-art training not available in a local setting. These programs would be required to advertise broadly, select participants from a national solicitation, and bring together individuals from diverse backgrounds with the goal of enriching the ideas and scientific vision of all participants.
                                                              n/a2023/09
                                                              NINDS Research Education Program to Support Residents and Fellows
                                                              Michael Tennekoon
                                                              Pursuit of research by clinicians has become increasingly difficult and time-consuming. For optimal success, residents must remain involved in research during residency and fellows must have a secure means of support to pursue research during their fellowship. This concept aims to enhance the pipeline of residents and fellows for research careers and to shorten their training timeline. The overarching goal is to support residents and fellows preparing for clinician-scientist research careers that align with the NINDS mission.
                                                              n/a2023/09
                                                              Support of Research Excellence (SuRE) Program
                                                              Lauren Ullrich
                                                              This concept aims to build research capacity by developing and sustaining research excellence at higher education institutions that increase research competitiveness for under-resourced institutions with limited NIH research funding. The Support of Research Excellent (SuRE) concept aims to provide research grant support for investigator-initiated research projects with strong student participation, and to provide SuRE-eligible institutions with the tools and resources necessary to build research infrastructure.
                                                              n/a2023/09
                                                              NINDS Human Genetics Resource Center
                                                              Ran Zhang
                                                              The goal of this concept is to accelerate the discovery of genetic causes and risk factors for neurological disorders, particularly for complex diseases with multiple phenotypes. It aims to support the NINDS repository’s mission of offering biological sample collection, curation, storage, and distribution services to the scientific community.
                                                              n/a2023/09
                                                              NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention
                                                              Scott Janis
                                                              This concept aims to develop, promote, and conduct high-quality, multi-site clinical trials focused on key interventions for stroke prevention, treatment, and recovery to be conducted within the NIH Stroke Clinical Trials Research Network (NIH StrokeNet). Additionally, this concept aims to engage both the planning and execution of innovative studies designed to answer the highest priority clinical and scientific questions in stroke along with the larger US and international stroke research community.
                                                              n/a2023/09
                                                              Safety and Efficacy of Amyloid-Beta Directed Antibody Therapy in Mild Cognitive Impairment and Dementia with Evidence of Both Amyloid-Beta and Lewy Body Dementias
                                                              Rebecca Hommer
                                                              The concept aims to encourage the development and implementation of clinical trials to determine the efficacy and safety of amyloid-beta clearing monoclonal antibody therapies in patients with evidence of both amyloid-beta pathology and clinical Lewy Body Dementia (LBD).  LBD includes both Parkinson’s disease dementia (PDD and dementia with Lewy bodies (DLB). The overarching goal is to increase knowledge of the benefits and risks of amyloid-beta clearing antibody therapies in individuals with both amyloid-beta and LBD, a population that has not been systematically considered in pre-market studies and about whom potential benefits and harms of treatment remain unknown.
                                                              n/a
                                                              AD/ADRD2023/09
                                                              Analytical Validation of Biomarkers for Neurological or Neuromuscular Disorders
                                                              Carol Taylor-Burds
                                                              This concept aims to enable rigorous analytical validation of the detection methods used to measure biomarkers for neurological disorders. The concept aligns with the Food and Drug Administration (FDA) guidance for establishing the performance criteria needed to demonstrate technologies that are sufficiently accurate and reliable for measuring biomarkers in clinical trials. Activities supported within this concept could include but may not be limited to, optimizing, and evaluating the accuracy, precision, reportable range, and analytical sensitivity and specificity of the detection method across multiple sites and operators, as well as establishing reference intervals and quality control procedures.
                                                              n/a2023/09
                                                              Clinical Validation of Biomarkers for Neurological or Neuromuscular Disorders
                                                              Carol Taylor-Burds
                                                              This concept aims to enable rigorous fit for purpose multi-site clinical validation of biomarkers for neurological disorders, in alignment with the Food and Drug Administration (FDA) guidelines. This concept may support candidate biomarker(s) that have already been identified and undergone preliminary evaluation in a clinical population, and for which the detection method for measuring the biomarker has already been developed and analytically validated. The research scope for this concept may include clinical prospective or retrospective studies to establish the statistical thresholds for decision-making within a specified context of use.
                                                              n/a2023/09
                                                              BRAIN Initiative: Preclinical Proof of Concept for Novel Recording and Modulation Technologies in the Human CNS
                                                              Brooks Gross
                                                              This concept aims to establish proof of concept for novel devices that record and/or modulate the human central nervous system (CNS). These efforts would support the development and preclinical testing of devices to further our understanding of the human CNS and treat nervous system disorders. This concept also would support translation of new devices up to the stage of readiness for first in human (FIH) clinical trials by overcoming key challenges identified during preliminary proof-of-concept studies.
                                                              n/a
                                                              BRAIN2023/09
                                                              CCRP Initiative: NIH Countermeasures Against Chemical Threats (CounterACT) Basic Research on Chemical Threats that Affect the Nervous System
                                                              Shardell Spriggs
                                                              This concept aims to support research on chemical threats that target the nervous system to gain a better understanding of the mechanisms of toxicity and identify targets for potential therapeutic interventions. The concept aligns with the 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 that can reduce mortality and morbidity in the event of the release of chemical threat agents that may be threats to the US population.
                                                              n/a2023/09
                                                              BRAIN Initiative Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System
                                                              Megan Frankowski
                                                              This concept aims to encourage milestone-driven translational and clinical research projects for recording and/or stimulating devices to treat central nervous system (CNS) disorders and to better understand the human brain. As recommended in the BRAIN 2.0 Report, the overarching goal of this concept is to support the pre-clinical regulatory activities necessary for initial clinical studies of "implantable devices with recording and/or stimulation capabilities that both advance clinical diagnostic or therapeutic applications and maximize their scientific research value," and a subsequent small clinical trial for such devices.
                                                              n/a
                                                              BRAIN2023/09
                                                              BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System
                                                              Megan Frankowski
                                                              This concept aims to encourage first-in-human or early-stage clinical studies for recording and/or stimulating devices to treat central nervous system disorders and to better understand the human brain. As recommended in the BRAIN 2.0 Report, the overarching goal of this concept is to support early feasibility and first in human clinical studies of "implantable devices with recording and/or stimulation capabilities that both advance clinical diagnostic or therapeutic applications and maximize their scientific research value."
                                                              n/a
                                                              BRAIN2023/09
                                                              Translational Neural Devices
                                                              Nick Langhals
                                                              The goal of this concept is to encourage translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The concept aims to support activities such as implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical study.
                                                              n/a2023/05
                                                              Undiagnosed Diseases Network (UDN)
                                                              Argenia Doss
                                                              The goal of this concept is to continue to provide a broad range of expertise for undiagnosed disease patients through the Undiagnosed Diseases Network (UDN). The NIH Common Fund created UDN to foster collaboration between clinicians and basic researchers for better understanding of underlying mechanisms for these diseases, provide a diagnosis, and identify treatment strategies. Furthermore, the NIH aims for the UDN to provide expert diagnostic services to broader populations, including implementing strategies to expand equity and access to individuals in the US specifically from populations defined by the NIH to experience health disparities.
                                                              n/a2023/05
                                                              Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
                                                              Vicky Whittemore
                                                              The goal of this concept is to support research that focuses on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) through multi-disciplinary approaches. The concept encourages investigator(s)-initiated applications that propose to examine the etiology, diagnosis, pathophysiology and manifestations of ME/CFS in diverse groups and across the lifespan.
                                                              n/a2023/05
                                                              Clinical Trial Methods in Neurological Disorders Course
                                                              Sophie Cho
                                                              The overarching goal of this concept is to identify promising investigators new to clinical research, and to promote training of this workforce with the long-term goal of increasing the reliability and effectiveness of clinical trials. The concept aims to 1) introduce the principles of good clinical practice to investigators in any clinical neuroscience subspecialty 2) expose early career clinical scientists to the foundations for scientifically rigorous and ethical performance of patient oriented clinical research and, 3) increase the number and expertise of knowledgeable clinical research investigators in the workforce to enhance the pipeline of scientifically sound, well-designed clinical trials.
                                                              n/a
                                                              `2023/05
                                                              NIH Blueprint and BRAIN Initiative D-SPAN Award
                                                              Lauren Ullrich
                                                              The goal of this concept is to support a defined pathway across career stages for outstanding graduate students who are from diverse backgrounds, including those underrepresented in neuroscience research through Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award. This award aims to empower trainees from diverse backgrounds to find postdoctoral environments that match their skills and scientific interests with minimal financial constraints by providing continuous support throughout the critical postgraduate career stage. The funding stability and professional development benchmarks will allow D-SPAN awardees to structure a specific plan forward in their early career as a researcher.
                                                              n/a2023/05
                                                              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/a2023/05
                                                              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/a2023/05
                                                              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/a2023/05
                                                              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/a2023/05
                                                              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/a2023/05
                                                              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/a2023/05
                                                              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/ADRD2023/05
                                                              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/ADRD2023/05
                                                              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/ADRD2023/05
                                                              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
                                                              HEAL2023/02
                                                              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/a2023/02
                                                              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 4:21:002023/02
                                                              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/a2023/02
                                                              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/a2023/02
                                                              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/a2023/02
                                                              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/a2023/02
                                                              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 4:40:002023/02
                                                              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 4:17:002023/02
                                                              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/a2023/02
                                                              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/a2023/02
                                                              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 4:25:002023/02
                                                              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/ADRD2023/02
                                                              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/ADRD2023/02
                                                              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/ADRD2023/02
                                                              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/ADRD2023/02
                                                              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/ADRD2023/02
                                                              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/ADRD2023/02
                                                              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/ADRD2023/02
                                                              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/ADRD2023/02
                                                              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/ADRD2023/02
                                                              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/ADRD2023/02
                                                              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
                                                              HEAL2023/02
                                                              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
                                                              HEAL2023/02
                                                              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
                                                              HEAL2023/02
                                                              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
                                                              HEAL2023/02
                                                              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
                                                              HEAL2023/02
                                                              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
                                                              BRAIN2022/10
                                                              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 3:06:002022/10
                                                              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 3:16:002022/10
                                                              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 2:59:002022/10
                                                              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/a2022/10
                                                              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/a2022/10
                                                              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/a2022/05
                                                              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
                                                              HEAL2022/05
                                                              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
                                                              HEAL2022/05
                                                              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
                                                              HEAL2022/05
                                                              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
                                                              HEAL2022/05
                                                              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
                                                              HEAL2022/05
                                                              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
                                                              HEAL2022/05
                                                              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/a2022/05
                                                              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/a2022/05
                                                              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 3:27:452022/05
                                                              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/a2022/05
                                                              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/a2022/05
                                                              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
                                                              BRAIN2022/05
                                                              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
                                                              BRAIN2022/02
                                                              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/a2022/02
                                                              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 4:02:472022/02
                                                              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/a2022/02
                                                              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/a2022/02
                                                              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/a2022/02
                                                              Education Program on Translational Devices
                                                              Brooks Gross
                                                              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/a2022/02
                                                              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/a2022/02
                                                              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/a2021/10
                                                              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
                                                              HEAL2021/10
                                                              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
                                                              HEAL2021/10
                                                              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
                                                              HEAL2021/10
                                                              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
                                                              HEAL2021/10
                                                              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
                                                              HEAL2021/10
                                                              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 4:18:102021/10
                                                              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 4:24:202021/10
                                                              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 4:30:182021/10
                                                              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 4:43:402021/10
                                                              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/a2021/10
                                                              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/a2021/10
                                                              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
                                                              BRAIN2021/10
                                                              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/a2021/10
                                                              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/a2021/10
                                                              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/a2021/10
                                                              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 Funding
  
    

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                                      Collaborative Opportunities for Multidisciplinary, Bold, and Innovative Neuroscience (COMBINE) (RM1)
                                                              
                    
                                      FAQS - NINDS Combine RM1
    
            PEDP - NINDS Interdisciplinary Team Science Grant (RM1 Clinical Trial Optional)Cooperative Agreements
    
            Conference and Supporting Resources
                                                              
                    
                                      R13/U13 GuidelinesAdministrative Supplements
    
            Contracts
                                                              
                    
                                      Contract Solicitations
    
            Contract ResourcesFind Your NINDS Program Officer
                                                              
                    
                                      Find Your Program Officer-Decision TreePreparing Your Application
                                                              
                    
                                      The Application Process
                                                              
                    
                                      Pre-Submission Approval Large Budgets
    
            Pre-Submission Approval R13/U13
    
            Late ApplicationsDetermining Eligiblity
                                                              
                    
                                      Foreign Eligibility
    
            New and Early Stage InvestigatorsAssembling a Team
    
            Preparing a Budget
                                                              
                    
                                      Salary Cap, Stipends, & Training Funds
    
            Creating a Budget
    
            Subaward BudgetsPreparing a Research Plan
                                                              
                    
                                      Rigorous Study Design and Transparent Reporting
    
            Writing For Reviewers
    
            Writing Specific Aims
    
            Writing a Research StrategyAdditional Application Forms
    
            Human Subject Clinical Trials
    
            Vertebrate Animals
    
            Data Management and Sharing Plan
                                                              
                    
                                      NINDS Interpretation of the NIH GDS PolicySubmission Troubleshooting and Technology
        
  
              
    
            After You Submit
                                                              
                    
                                      Tracking Your Application
    
            Understanding the Review Process
                                                              
                    
                                      First-Level Peer Review
    
            Scoring and Summary Statements
    
            Second-Level Peer ReviewDetermining Your Funding Likelihood
                                                              
                    
                                      Post Review: Next Steps
    
            Understanding Paylines
    
            NINDS Paylines
    
            Funding Beyond Payline (Select Pay)
    
            Funding Outcomes Data
                                                              
                    
                                      FY22 Total Extramural Research ExpendituresManage Your Award
                                                              
                    
                                      Pre-Award
                                                              
                    
                                      Just-In-Time Process
    
            Rules and Policies for Funding Consideration
    
            Negotiate Your Award
    
            Applications with Foreign Components
    
            Notice of AwardDuring Award
                                                              
                    
                                      Change in Scope or Data Sharing
    
            Change in PI or Senior/Key Personnel
    
            Change of Institution
    
            Carryover
    
            Reporting Requirements
    
            Supplements
    
            Phased and Transition Awards
    
            No-Cost ExtensionEnd of Award
        
  
              
    
            NINDS Small Business Program
                                                              
                    
                                      Small Business Frequently Asked Questions (FAQs)
    
            Types of NINDS Small Business Grants
    
            Areas of Interest
    
            Submitting a Small Business Application
    
            NINDS SBIR/STTR Funding Decision Process
    
            Company Showcase
    
            Awardee ResourcesTraining & Career Development
                                                              
                    
                                      Choose an Award by Career Stage & Eligibility
                                                              
                    
                                      High School, Undergraduate, & Post-Baccalaureate
    
            Predoctoral Fellows
    
            Postdoctoral Fellows
    
            Clinician Scientist
    
            Faculty
    
            Diversity AwardsChoose an Award by Program Type
                                                              
                    
                                      Individual Fellowships
    
            Career Development Awards
    
            Institutional Grants
    
            Other Training-Related Programs

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      Last reviewed on April 10, 2024
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