NEUROLOGICAL BASIS OF RECURRENT HEADACHE, ESPECIALLY MIGRAINE NIH GUIDE, Volume 21, Number 41, November 13, 1992 PA: PA-93-019 P.T. 34 Keywords: Neurological Disorders Pathophysiology Hormones Etiology Disease Prevention+ Risk Factors/Analysis National Institute of Neurological Disorders and Stroke PURPOSE The Division of Stroke and Trauma (DST), National Institute of Neurological Disorders and Stroke (NINDS), invites applications for support of research that will increase our understanding of the causes of, and add to our ability to treat and prevent, recurrent headache, especially migraine. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic institutions, for-profit and non-profit organizations, public or private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are eligible to apply for research project grants (R01) only. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority institutions, minority individuals, and women are particularly encouraged. MECHANISMS OF SUPPORT The support mechanisms for grants in this area will be the traditional investigator-initiated research project grant (R01), the FIRST award (R29), the program project grant (P01), and the center grant (P50). As consistent with the aforementioned mechanisms, the Principal Investigator or program director, as well as any participating investigators, will plan, direct, and perform the research. Applicants for program project grants should contact the NINDS representative listed below as early as possible in the planning stages. RESEARCH OBJECTIVES Background Millions of Americans suffer from recurrent headaches. For many, the headaches are of such severity that they are disabling. In addition to the profound effects on the quality of life for these people, the economic consequences are enormous. Some estimates are that headache sufferers seek medical care through over eight million visits to physicians or emergency rooms each year. Other estimates of the impact of this condition are that migraineurs alone lose over sixty million workdays a year. A major research goal of the NINDS, which is the responsible agency for neurological research in the Federal Government, is to understand the basic pathophysiology of headaches and to use this understanding to improve methods for treatment and prevention of recurrence. Headaches can be classified as vascular headaches, muscle contraction headaches, tension headaches, or inflammatory headaches, to mention but a few. Vascular headaches are thought to involve abnormal function of the brain's blood vessels or vascular system. The most common type of vascular headache is migraine headache, the cause of which is still not known. Migraine headaches are frequently characterized by severe pain on one or both sides of the head, nausea, and extreme sensitivity to light and noises. The two most prevalent types of migraine headache are the classic migraine and the common migraine. The major difference between these two types of migraine is that the victim of a classic migraine experiences an aura about 10 to 30 minutes before the onset of headache. This aura is the major prodromal neurological symptom and warning of the imminent onset of the classic migraine. The pain of a migraine headache is described as an intense, throbbing, or pounding pain in the forehead, temple, ear, jaw, or around the eye; these pains may continue for several days. The common migraine is not preceded by an aura; however, some people who are subject to the common migraine exhibit a variety of vague symptoms before the onset of the headache, such as mood shifts, fatigue, and abnormal retention of fluids. The pain of common migraine can also last several days, during which the victim may have nausea or vomiting. Research Goals and Scope Examples of investigator-initiated research grant applications for basic and clinical studies related, in the broadest sense, to the etiology, prevention, and treatment of recurrent headache, especially migraine headache, may include, but should not necessarily be limited to: o precise elucidation of the cellular and molecular events that cause or lead to headaches; o development of more specific clinical interventions for both prevention and treatment of migraine headaches, such as anti-platelet clumping drugs; more efficacious anti-serotonin drugs or other means of preventing or reducing the constriction of arteries; and site-specific anti-prostaglandins; o development of methods for precisely identifying the sequence of alterations in blood flow or vascular reactivity that may be an initiating factor for migraine; o identification of risk factors, or events, that predispose the migraineur to an attack, such as stress, allergies, diet, sleeping patterns, neuroses, personality type, and behavioral characteristics such as excitability and compulsiveness; o control of risk factors in relation to the prevention of a migraine headache; o longitudinal epidemiology of the distribution and inter-relation between risk factors and the predisposition to an attack of migraine headache; o determination of whether or not genetic factors predispose to migraines, and, if so, identification of the genetic locus with a view toward understanding the causative or contributory mechanisms and developing a means of preventing migraine headache; and o determination of the relation between hormones and migraine. POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial or ethnic group. In addition, gender and racial or ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups; however, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of Unites States racial or ethnic minority populations: Native Americans (including American Indians or Alaska Natives), Asian or Pacific Islanders, Blacks, and Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and prevention strategies), diagnosis, or treatment of diseases, disorders, or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded; however, every effort should be made to include human tissues from women and racial or ethnic minorities when it is important to apply the results of the study broadly. This directive should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully. Since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' population, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION AND REVIEW PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) according to the instructions included in the application package. These application packages are available at the offices of sponsored research of most institutions eligible to receive Federal grants and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. Applicants for program project grants should request, from the address below, a copy of the NINDS Guidelines: Program Project and Research Center Grants (rev. June 1992). Receipt dates for new research project grant applications and FIRST Awards (R01 and R29, respectively) and for program project and center grant applications (P01 and P50, respectively) are February 1, June 1, and October 1. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. On page 1 of form PHS 398, check "yes" in Item 2a, enter the number of this Program Announcement in the space provided, and provide the name of this Program Announcement (Neurological Basis of Recurrent Headaches, Especially Migraine) in the blank space labeled "Title." Use the mailing label provided in the application package to mail the signed original and five exact copies to the Division of Research Grants. If the application is for a program project or center grant, please send the original and three copies to the Division of Research Grants. An additional two copies of the program project or center grant application sent to the address below would be useful for expediting the processing of these applications for multidisciplinary efforts. REVIEW CONSIDERATIONS Research project grant applications and FIRST award applications (R01 and R29, respectively) will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Program project grant and center grant applications (P01 and P50, respectively) will be reviewed according to the practice of the Institute to which the application is assigned. The second level of review will be by the appropriate National Advisory Council. The standard review criteria will be used to assess the scientific merit of applications. AWARD CRITERIA Applications will compete for available funds with all other applications. The following will be considered when making funding decisions: o quality of the proposed projects as determined by peer review o availability of funds o program balance among research areas INQUIRIES Questions concerning scientific aspects of this PA may be addressed to: Dr. George N. Eaves Division of Stroke and Trauma National Institute of Neurological Disorders and Stroke Federal Building, Room 8A13 Bethesda, MD 20892 Telephone: (301) 496-4226 FAX: (301) 480-1080 Questions concerning fiscal aspects of this PA may be addressed to: Ms. Kathleen Howe Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance, No. 93.853, Clinical Research Related to Neurological Disorders, and 93.854, Biological Basis Research in the Neurosciences. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410, as amended: 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR 74. This program is not subject to Health Services Agency review of the intergovernmental review requirements of Executive Order 12372. .
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