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 
http://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 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, 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 
http://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 
http://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: 
http://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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://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
http://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 
http://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 
http://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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