RFA-DC-03-003: THE ROLE OF NEUROIMAGING IN APHASIA REHABILITATION

THE ROLE OF NEUROIMAGING IN APHASIA REHABILITATION RELEASE DATE: January 8, 2003 RFA: DC-03-003 National Institute of Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/) LETTER OF INTENT RECEIPT DATE: July 3, 2003 APPLICATION RECEIPT DATE: July 29, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations: PURPOSE OF THIS RFA The purpose of this RFA is to solicit applications that examine the potential of neuroimaging technology in the rehabilitation of patients with aphasia. Applications must involve a multi-disciplinary team. RESEARCH OBJECTIVES In adults, the term "aphasia" is typically defined as the language problems (comprehension and/or expression) resulting from stroke. It is estimated that in the US approximately 80,000 individuals become aphasic each year and that one million persons currently have aphasia. A number of studies have shown that the language deficits of aphasia often are amenable to treatment, both at onset, and many years beyond. Various treatments are available, but robust data affirming their efficacy are limited. The NIDCD has a longstanding commitment to research in the treatment of adult aphasia, including a 1991 NIDCD-sponsored workshop on the topic, a resulting monograph, and an RFA "Treatment and Rehabilitation of Adult Aphasia". Recent advances in neuroimaging technology have enabled researchers to more clearly document the site and extent of lesion, as well as understand and explicate the language deficits associated with the lesion. In addition, these technologies have provided a potential mechanism for investigating a number of treatment- related issues, including prognosis for recovery, the potential of specific neural tissue to be recruited in recovery, and the differential effects of various treatment aspects on neural activity. Given these developments, and continued NIDCD and Congressional interest in aphasia, a workshop (The Role of Neuroimaging in the Study of Aphasia Recovery and Rehabilitation: Research Needs and Opportunities) held on the NIH campus in May, 2002. The goals included 1) the identification of research opportunities for the application of neuroimaging methods to the study of aphasia recovery and rehabilitation; and 2) the methodological challenges of imaging research focusing on the issue of aphasia recovery and rehabilitation. Research recommendations included: 1)neuroimaging relevant to the study of aphasia; 2) recovery from aphasia/ brain damage; and 3) aphasia rehabilitation (both the neuroimaging/ rehabilitation interface as well as treatment-specific issues). A summary of the workshop recommendations is available (http://www.nidcd.nih.gov/funding/programs/vsl/aphasiawrkshop.asp). Many of the research opportunities identified at the workshop do not fall within the scope of this RFA; for those areas, NIDCD encourages investigator-initiated research applications. In view of the exciting and significant opportunities, this initiative is designed to encourage investigations into neuroimaging and its role in aphasia recovery and rehabilitation. Research examining the neural correlates of recovery from aphasia is important to further our understanding of neural plasticity in general and more specifically, the neural mechanisms of language recovery. Such studies have the potential to impact the clinical treatment of individuals with aphasia, including the ability to predict potential for recovery and to guide prescription of specific treatments for patients with particular language deficits. Research is needed to fully capitalize on the potential of neuroimaging in the rehabilitation of patients with aphasia. Many remaining technical and analytical issues require a multi-disciplinary approach. Examples of studies include, but are not limited to, the following: o Determine possible modifications in neuroimaging methodology, data collection and analysis, required for this population, addressing issues related to linguistic/cognitive task difficulty; pooling of patient data (for example, lesion location, language abilities); test- retest reliability; cross-session image alignment; and temporal stability of imaging results, o Develop new methods for imaging language production, o Develop techniques to document neurobiological correlates of treatment effects, o Determine the utility of neuroimaging to predict functional outcomes, or the type(s) of aphasia most likely to benefit from particular treatments, o Examine the use of neuroimaging to predict likelihood of retention of skills post treatment, and o Examine the role of neuroimaging in documenting recovery from aphasia, including changes over time in patterns of performance and neurobiological processes. MECHANISM(S) OF SUPPORT This RFA will use NIH R01 and R21 Exploratory Research award mechanisms. The R21 mechanism should be used for pilot or preliminary studies that will lead to larger-scale, R01-type investigations. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. You may only submit one application in response to this announcement. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is April, 2004. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. FUNDS AVAILABLE NIDCD intends to commit approximately $1.5 million in FY 04 to fund 3 to 4 new grants in response to this RFA. NIBIB intends to commit approximately $250,000 in FY 04. For R01s, an applicant may request a project period of up to 5 years and a budget for direct costs of up to $500,000 per year. For R21 applications, an applicant may request a project period of up to 2 years and a budget for direct costs of up to $100,000 per year. 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 NIDCD and NIBIB provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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 programs. SPECIAL REQUIREMENTS The Principal Investigator may submit only one application in response to this RFA. The Principal Investigator must have research expertise in aphasia, neuroimaging and/or rehabilitation. Investigators without this expertise will be considered non-responsive to the RFA. The application must involve an interdisciplinary team that includes, at a minimum, expertise in aphasia, neuroimaging, and rehabilitation. Multi-site collaborations are encouraged. R01 applications must include both neuroimaging and aphasia rehabilitation components. R21 applications may focus on collecting pilot data or conducting preliminary studies in one or both areas. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: o Direct your questions about scientific/research issues to: Judith A. Cooper, Ph.D Scientific Programs Branch NIDCD EPS, Room 400-C Bethesda, MD 20892 Telephone: (301) 496-5061 FAX: (301) 402-6251 Email: Judith_Cooper@NIH.GOV Alan McLaughlin, Ph.D. Program Director National Institute of Biomedical Imaging and Bioengineering NIH/DHHS 6707 Democracy Blvd, Suite 200 Bethesda, MD 20892-5477 Telephone: (301) 496-9321 Fax: (301) 480-4973 Email: mclaugal@mail.nih.gov o Direct your questions about peer review issues to: Craig Jordan, Ph.D. Scientific Review Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400C, MSC-7180 Bethesda, MD 20892-7180 Telephone: 301-496-8683 Fax: 301-402-6250 Email: jordanc@nih.gov o Direct your questions about financial or grants management matters to: Sara Stone Grants Management Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400B, MSC-7180 Bethesda, MD 20892-7180 Telephone: 301-402-0909 Fax: 301-402-1758 Email: stones@nidcd.nih.gov Mr. Nicholas T. Mitrano Grants Management Specialist Grants Management Branch Division of Extramural Activities National Institute of Biomedical Imaging and Bioengineering NIH/DHHS 6707 Democracy Blvd, Suite 900 Bethesda, MD 20892-5469 Telephone: (301) 451-4782 FAX: (301) 480-4974 Email: mitranni@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 NIDCD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by July 3, 2003 to: Judith A. Cooper, Ph.D Scientific Programs Branch NIDCD EPS, Room 400-C Bethesda, MD 20892 Telephone: (301) 496-5061 FAX: (301) 402-6251 Email: Judith_Cooper@NIH.GOV SUBMITTING AN APPLICATION R01 applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). R21 applications should follow the same instructions; these applications are limited to 10 pages. Appendices for R21 applications are limited to 3 items, including reprints or color figures. The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at https://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Chief, Scientific Review Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400C, MSC-7180 Bethesda, MD 20892-7180 Rockville, MD 20851 (for express/courier service) Appendices should not be sent to the Center for Scientific Review and should be sent to: Chief, Scientific Review Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400C, MSC-7180 Bethesda, MD 20892-7180 Rockville, MD 20851 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NIDCD and NIBIB. Incomplete applications will be returned to the applicant without further consideration. If the R01 application is not responsive to the RFA, staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Non-responsive R21 applications will be returned to the applicant. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Deafness and Other Communication Disorders Advisory Council and the National Advisory Council for Biomedical Imaging and Bioengineering. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o OTHER REVIEW CRITERIA: For R01s: The strength and expertise of the multidisciplinary team. The merit and significance of both the neuroimaging component as well as the aphasia rehabilitation component. The research expertise of the Principal Investigator in aphasia, neuroimaging and/or rehabilitation. (Investigators without this expertise will be considered non-responsive to the RFA.) For R21s: The likelihood that the exploratory grant will lead to a future R01 submission focused on the role of neuroimaging in aphasia rehabilitation. The merit and significance of the neuroimaging component and/or the aphasia rehabilitation component. The research expertise of the Principal Investigator in aphasia, neuroimaging and/or rehabilitation. (Investigators without this expertise will be considered non-responsive to the RFA.) RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: July 3, 2003 Application Receipt Date: July 29, 2003 Peer Review Date: November,2003 Council Review: January, 2004 Earliest Anticipated Start Date: April, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_ 2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/document/html HP2010 includes Chapter 6 on "Disability and Secondary Conditions" that addresses rehabilitative needs of adults with disabilities. http://www.health.gov/healthypeople/Document/HTML/Volume1/06Disability.htm AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.173 (NIDCD) and 93.286 and 93.287 (NIBIB), and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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