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    Migraine_neural_mechanisms_and_risk_factors_for_progression ... Migraine_neural_mechanisms_and_risk_factors_for_progression ... Document Transcript

    • Migraine: Neural Mechanisms and Risk Factors for TÍTULO DE LA ACCIÓN Progression (R01) CÓDIGO IDENTIFICATORIO DE LA ACCIÓN Request for Applications (RFA) Number: RFA-NS-07-005 FECHA DE Release/Posted Date: January 17, 2007 PUBLICACIÓN FECHA DE CIERRE DE Opening Date: March 16, 2007 (Earliest date an application may be submitted to Grants.gov) SOLICITUDES Letters of Intent Receipt Date(s): March 16, 2007 NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). Application Receipt Date: April 16, 2007 Peer Review Date(s): June/July, 2007 Council Review Date: August, 2007 Earliest Anticipated Start Date(s): September 30, 2007 Additional Information To Be Available Date (URL Activation Date): Not Applicable Expiration Date: April 17, 2007. ORGANISMOS Participating Organizations CONVOCANTES National Institutes of Health (NIH) (http://www.nih.gov) Components of Participating Organizations National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) 1
    • TEMÁTICA Research Objectives PURPOSE The purpose of this funding opportunity announcement (FOA) is to stimulate promising new avenues of research that will apply the novel theories of neural mechanisms underlying migraine headache and technological advances to address the progressive nature of migraines. This FOA also is intended to attract new expertise to the field of migraine research to advance the field rapidly and effectively. BACKGROUND Migraine is a disabling chronic pain disorder that affects people of all ages. It often extends from childhood into adulthood and may persist throughout a person’s lifespan. It is an enormous burden to the healthcare system. Eighteen to 20% of the population suffers from headache pain. A significant proportion of migraine sufferers have headaches that are not responsive to current therapies and increase in frequency over time, eventually becoming chronic daily headaches (15 or more headaches/month). As imaging technology is more widely used in headache diagnosis, it is increasingly evident that frequent migraines are associated with risk for potentially serious neurological damage. Patients with chronic and frequent headaches show increased incidence of subcortical white matter and cerebellar lesions. Migraineurs, especially those who experience migraine auras are more likely to suffer ischemic strokes than non-migraineurs. In addition, frequent headaches often occur with other chronic pain conditions. Risk factors and predictors for transition from infrequent to chronic daily headaches need to be identified and understood in order to develop preventive therapies. Evolving theories on the mechanisms underlying migraine aura and pain may aide in understanding the susceptibility for increasing headache frequency and the high incidence of co-morbid pain disorders. In addition, the mechanisms linking frequent headaches with heightened susceptibility to nervous system lesions, stroke, and other co-morbid pain conditions need exploration. A better understanding of the effects of recurrent migraines on nervous tissue structure and function may reveal the mechanisms responsible for neural damage. 2
    • SUBTEMÁTICA OBJECTIVES Risk factors have emerged as potential contributors to the progression from infrequent to chronic daily headache, including life style, genetic influences, age, and physiology. Other factors may contribute to increased likelihood of stroke and co-morbid pain conditions. It is important to identify the subpopulation of patients at risk in order to develop preventive measures and improve therapies. Identification of risk factors may offer clues to better understanding of the mechanisms underlying susceptibility to secondary neurological consequences. The research community is encouraged to recognize the importance of recent research findings on the pathophysiology, relevant genetic mutations, and neuronal consequences of migraine and to apply appropriate advances in technology, such as imaging and nanotechnology to aid future discoveries related to the mechanisms and consequences of migraine progression. Researchers with expertise in related areas, such as channel structure and function, ischemic stroke, neurovascular biology, and genetics are well positioned to contribute to new avenues of discovery in migraine research and are encouraged to apply. Areas of research solicited by this FOA include, but are not exclusive of, the following: • Identification of biomarkers for risk of headache progression • Identification and better understanding of predictive factors for headache progression and for treatment outcomes • Understanding of the differences between childhood and adult headaches and headache progression throughout the lifespan • Identification of genetic factors and mutations for susceptibility to increasing migraine frequency and associated neurological consequences of migraine progression • Understanding of the underlying mechanisms of migraine aura and pain as they relate to headache chronicity and progression • Identification of behavioral, physiological, or environmental risk factors for migraine progression and neurological consequences such as lesions and stroke • Understanding of the mechanisms that lead to increased susceptibility to pain conditions that are co-morbid with chronic headaches • Development of therapies to prevent progression of headaches and susceptibility to co-morbid conditions such as lesions and stroke • Assess structural and functional consequences of frequent headaches Mechanism of Support PECULIARIDADES This Funding Opportunity Announcement (FOA) will use the NIH Research Project Grant (R01) award mechanism. This FOA will not accept applications that include clinical trials of potential therapies. Applications proposing clinical trials (pilot, phase I, phase II, phase III) are considered under established specific mechanisms for supporting these types of proposals, including the unsolicited R01 or the Preliminary Investigations Leading to Optimal Trials in Neurology announcement (http://grants.nih.gov/grants/guide/ pa-files/PAR-03-174.html). The applicant will be solely responsible for planning, directing, and executing the proposed project. This FOA uses “Just-in-Time” information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are a U.S. organization and are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide). 3
    • Funds Available AVANCE SOBRE FINANCIACIÓN Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The participating organization(s), NINDS, intends to commit approximately $1.1 million dollars in fiscal year 2007to fund 3 to 4 applications. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004. CONDICIONES DE PARTICIPACIÓN Eligible Institutions You may submit an application(s) if your institution/organization has any of the following characteristics: • Public/State Controlled Institution of Higher Education • Private Institution of Higher Education • Hispanic-serving Institution • Historically Black Colleges and Universities (HBCUs) • Tribally Controlled Colleges and Universities (TCCUs) • Alaska Native and Native Hawaiian Serving Institutions • Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education) • Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education) • Non-domestic (non-U.S.) Entity • Small Business • For-Profit Organization (Other than Small Business) Eligible Individuals Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions). The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi. 4
    • LIMITACIONES A LA Foreign Organizations (Non-domestic (non-U.S.) Entity) PARTICIPACIÓN NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260. Applications from foreign organizations must: • Request budgets in U.S. dollars. • Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms – not the PHS398 Modular Budget component). See NOT-OD-06-096. • Charge back of customs and import fees is not allowed. • Format: Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5” x 11” within each PDF. • Funds for up to 8% administrative costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001. • Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards. • Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., “Administrative and National Policy Requirements.” Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources. ACCESO FORMULARIOS Letter of Intent Prospective applicants are asked to submit a letter of intent that includes the following information: • Descriptive title of proposed research. • Name, address, and telephone number of the PD(s)/PI(s). • Names of other key personnel. • Participating institutions. • Number and title of this funding opportunity. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed in Section IV.3.A. The letter of intent should be sent to: Linda L. Porter, Ph.D. National Institute of Neurological Disorders and Stroke 6001 Executive Blvd NSC, 2113 Bethesda, MD 20892 Telephone: (301) 496 9964 Fax: (301) 402-2060 Email: Porterl@ninds.nih.gov A letter of intent is not required, but encouraged, for the funding opportunity. Submitting an Application Electronically to the NIH To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. In order to expedite the review, applicants are requested to notify the NINDS Referral Office by email (nindsreview.nih.gov@mail.nih.gov) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application. 5
    • INFORMACIÓN Agency Contacts PERSONALIZADA We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: 1. Scientific/Research Contact(s): Linda L. Porter, Ph.D. National Institute of Neurological Disorders and Stroke NSC, Room 2113 6001 Executive Blvd. Bethesda, MD 20892-9521 Telephone: (301) 496-9964 Fax: (301) 402-2060 Email: porterl@ninds.nih.gov 2. Peer Review Contact(s): Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke Room 3201, MSC 9529 6001 Executive Boulevard Bethesda, MD 20892-9529 (use Rockville, MD 20852 for express/courier service) Telephone: (301) 496-9223 Fax: (301) 402-0182 Email: nindsreview.nih.gov@mail.nih.gov 3. Financial/Grants Management Contact(s): Ms. Maxine Davis-Vanlue Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Suite 3254, MSC 9537 Bethesda, MD 20892-9537 (use Rockville, MD 20852 for express/courier service) Telephone: (301) 496-9231 Fax: (301) 402-0219 Email: davisma@ninds.nih.gov LINK INFORMATIVO http://grants.nih.gov/grants/guide/rfa-files/RFA- NS-07-005.html#SectionIII PARA INFORMACIÓN GENERAL SOBRE LA CONVOCATORIA. CONTACTO EN EL INSTITUTO DE SALUD CARLOS III: carmen.miguelez@isciii.es 6