SYMPTOM MANAGEMENT FOR CHRONIC NEUROLOGICAL CONDITIONS

Release Date:  February 23, 1998

PA NUMBER: PA-98-030

P.T.

National Institute of Nursing Research
National Institute on Aging
National Institute of Child Health and Human Development
National Institute on Deafness and Other Communication Disorders
National Institute of Neurological Disorders and Stroke

PURPOSE

The National Institute of Nursing Research (NINR), National Institute on Aging
(NIA), National Institute of Child Health and Human Development (NICHD), National
Institute on Deafness and Other Communication Disorders (NIDCD), and National
Institute of Neurological Disorders and Stroke (NINDS) are interested in
facilitating investigator-initiated research designed to deal with symptoms
associated with chronic neurological conditions including stroke, epilepsy, brain
and spinal cord injury, multiple sclerosis, and Parkinson's disease.  The overall
goals are to manage symptoms effectively, to prevent secondary effects of the
condition when possible, to maximize the health potential, and to improve the
health-related quality of life for patients, caregivers, and families.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This Program Announcement (PA), Symptom
Management for Chronic Neurological Conditions, is related to the priority area
of chronic disabling conditions. Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: 
Stock No. 017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

Research applications may be submitted by domestic and foreign, for-profit and
non-profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

The mechanism of support will be the National Institutes of Health (NIH) research
project grant (R01).  Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant.

RESEARCH OBJECTIVES

Background

Chronic neurological conditions, including stroke, epilepsy, brain and spinal
cord injury, multiple sclerosis, and Parkinson's disease are particularly
disabling illnesses experienced by a significant proportion of the United States
population.

Individuals living with a chronic neurological condition may experience a wide
variety of symptoms that require health care services and significantly interfere
with health-related quality of life and functional abilities. Health care
providers need effective strategies to assist individuals with these chronic
illnesses and their consequences.  Research is needed to determine factors that
contribute to these conditions and on methods to deter, ameliorate, or prevent,
where possible, the symptoms or their sequelae. Since these conditions affect
individuals across the life span and in a variety of settings including homes,
acute care, ambulatory care, and home health care, research is needed that
addresses the specific context and associated factors that may be important
including other factors such as age, gender, and minority status.  In addition,
family caregiving issues need to be considered in some studies in order to find
effective symptom management strategies to assist both the patient and the family
caregiver.  The overall goals of the symptom management strategies are to prevent
the onset of further disabilities, encourage independence, and enhance health-
related quality of life.

Patients who have had a stroke may experience a wide range of symptoms including
varying degrees of paralysis, weakness, spasticity, contractures, communication
(speech, voice and language) problems, swallowing problems, sensory deficits,
pain, visual losses, memory and reasoning deficits, depression, and coma.  These
symptoms may improve to some degree, but many individuals never fully recover and
need assistance throughout their remaining life. To date, scientific progress has
been made in understanding and preventing stroke and improving the emergency care
of stroke patients.  However, scientific evidence for dealing with the post-
stroke condition is extremely limited (AHCPR, 1995).

Advances in the treatment of epilepsy include implantable devices, new
antieplileptic drugs, and advances in surgery, imaging techniques, and genetics
research.  Despite these improvements, however, many patients with epilepsy
experience significant consequences of the seizure disorder, including physical
injuries, inadvertent responses to medications, psychological sequelae, learning
problems, and social difficulties including withdrawal and isolation.  Adherence
to treatment regimens is a critical issue that warrants additional research
attention in this population. Psychoeducational and behavioral interventions
designed to promote effective self-management and minimize or prevent the
consequences of epilepsy are important areas of needed investigation.

Brain and spinal cord injuries present management challenges in all phases
including limiting the immediate damage, handling the consequences of loss of
function, and encouraging functional recovery.  Research is needed to develop
improved methods of dealing with problems such as paralysis, spasticity,
cognitive and memory deficits, aggressive behavior and agitation, pain, pressure
ulcers, pulmonary difficulties, bone deterioration, muscle wasting, problems with
bowel and bladder function, and psychosocial aspects.  Investigations are also
needed on issues of nutrition, physical conditioning, and sleep in these
individuals.

The chronic, degenerative and sometimes intermittent nature of multiple sclerosis
is associated with neurological consequences such as numbness or tingling, vision
loss, weakness, paralysis, unsteady gait, vision difficulties, fatigue, heat
intolerance, and evolving communication difficulties.  Effective management
issues need to be tested for these symptoms in order to promote physical, mental,
and social health and well being.

Individuals who have Parkinson's disease experience rigidity, resting tremor,
bradykinesia, and loss of postural reflexes.  Secondary symptoms may include
depression; emotional changes; memory and sleep problems; changes in speech,
voice, and language production; urinary or bowel difficulties; low blood pressure
upon standing or problems in chewing or swallowing.  The symptoms may vary widely
across individuals and with time.

Objectives

Research applications may address issues related to managing the symptoms of
selected chronic neurological conditions, including stroke, epilepsy, brain and
spinal cord injury, multiple sclerosis, and Parkinson's disease. Research
objectives could include, but are not limited to:

o  Factors contributing to the improved physical and psychological status of
individuals with chronic neurological conditions,

o  Interventions to improve or maintain functioning, including physiological,
behavioral, cultural, and psychosocial aspects,

o  Methods to delay the progression of the condition or to prevent further
disability,

o  Strategies to deal with issues such as diet, fatigue, mobility, pain, physical
conditioning, sleep, stress, and depression,

o  Factors associated with family caregiving issues and adaptation strategies as
they relate to the health and quality of life of both the patient and caregiver.

Projects may be descriptive or experimental.  With adequate justification of
knowledge gaps, data may be collected that will enhance the development of
clinical interventions. However, where possible, interventions which are designed
to reduce the severity, frequency, duration or distress of symptoms should be
evaluated for efficacy under conditions that will permit comprehensive analysis
of appropriate outcome measures.  It is imperative that proposed interventions
not compromise the effectiveness of the treatment regimen.  Interventions should
also have the potential for implementation into routine clinical practice.

Because of the complex interaction of clinical symptoms and the associated
subjective response, a multidisciplinary research approach is recommended. 
Expertise from health-related disciplines should be included as appropriate for
both the target symptom and the clinical population.

Applicants are encouraged to make use of ongoing clinical trials or other medical
research efforts where feasible. Applications from institutions that participate
in ongoing clinical trials or have a General Clinical Research Center (GCRC) may
wish to identify these programs as a resource for conducting the proposed
research.  If so, a letter of agreement from the program director or the
Principal Investigator should be included with the application.

Related Program Announcements that may be of interest include:

PA-97-050:  Managing the Symptoms of Cognitive Impairment
PA-97-048:  Self-Care Behaviors and Aging
PA-97-024:  Spinal Cord Injury: Emerging Concepts
PA-96-032:  Communicative Competence of Users of Augmentative and Alternative
Communication (AAC) Systems
PA-95-056:  Biobehavioral Pain Research
PA-95-014:  Basic and Clinical Research on Sleep and Wakefulness
PA-95-034:  Evaluation, Treatment and Prognosis of the Communication Sequelae of
Traumatic Brain Injury

The full text of these program announcements may be accessed through the NIH
Guide for Grants and Contracts at http://www.nih.gov/grants/guide/index.html

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided 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 research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.

Investigators also may obtain copies of the policy from the program staff listed
under INQUIRIES.  Program staff may also provide additional relevant information
concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on grant application form PHS 398 (rev. 5/95)
and will be accepted at the standard application deadlines as indicated in the
application kit.  Application kits are available at most institutional offices
of sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email:
ASKNIH@od.nih.gov.  The title and number of the program announcement must be
typed in Section 2 on the face page of the application.

The complete original application and five legible copies must be sent or
delivered 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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines.  Applications that are complete will be evaluated for scientific and
technical merit by an appropriate peer review group convened in accordance with
the standard NIH peer review procedures.  As part of the initial merit review,
all applications will receive a written critique.  Applications will also undergo
a process in which only those deemed to have the highest scientific merit,
generally the top half of applications under review, will be discussed, assigned
a priority score, and receive a second level review by the appropriate national
advisory council or board, when applicable.

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 review, comments on the following aspects of the application will be made
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals.  Each of these criteria will
be addressed and considered in the assignment of the overall score:

(1) Significance

Does this study address an important problem?  If the aims of the application are
achieved, how will scientific knowledge be advanced?  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?  Does the applicant
acknowledge potential problem areas and consider alternative tactics?

(3) Innovation

Does the project employ novel concepts, approaches or methods?  Are the aims
original and innovative?  Does the project challenge existing paradigms or
develop new methodologies or technologies?

(4) Investigator

Is the investigator appropriately trained and well suited to carry out this work? 
Is the work proposed appropriate to the experience level of the principal
investigator and other researchers (if any)?

(5) Environment

Does the scientific environment in which the 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?

In addition, the adequacy of plans to include both genders and minorities and
their subgroups as appropriate for the scientific goals of the research will be
reviewed.  Plans for the recruitment and retention of subjects will also be
evaluated.

The initial review group will also examine the provisions for the protection of
human and animal subjects, the safety of the research environment, and
conformance with the NIH Guidelines for the Inclusion of Women and Minorities as
Subjects in Clinical Research.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to that institute or center. The following will be
considered in making funding decisions: quality of the proposed project as
determined by peer review, availability of funds, and program priority.

INQUIRIES

Inquiries are encouraged.  We welcome the opportunity to clarify any issues or
questions from potential applicants.

Direct inquiries regarding programmatic issues to:

Mary D. Leveck, Ph.D.,  R.N.
Scientific Program Administrator
National Institute of Nursing Research
Building 45, Room 3AN-12
Bethesda, MD  20892-6300
Telephone:  (301) 594-5963
FAX:  (301) 480-8260
Email:  mary_leveck@nih.gov

Louis A. Quatrano, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
Building 61E, Room 2AO3
Bethesda, MD  20892-7510
Telephone:  (301) 402-2242
FAX:  (301) 402-0832
Email:  LQ2N@nih.gov

Stephen Tuel, M.S.E., M.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
Building 61E, Room 2A03,  MSC-7510
Bethesda, MD  20892-7510
Telephone:  (301) 402-2242
FAX:  (301) 402-0832
Email:  tuels@box-t.nih.gov

Dr. Beth Ansel
Division of Human Communication
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC 7180
Bethesda, MD  20892-1780
Telephone:  (301) 402-3461
FAX:  (301) 402-6251
Email:  Beth_Ansel@NIH.GOV

Judith A. Finkelstein, Ph.D.
Sensory/Motor Disorders of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C307, MSC 9205
Bethesda  MD  20892-9205
Telephone:  (301) 496-9350
FAX:  (301) 496-1494
Email:  jf119k@NIH.GOV

Mary Ellen Cheung, Ph.D.
Division of Stroke, Trauma and Neurodegenerative Disorders
National Institute of Neurological Disorders and Stroke
Federal Building, Room 8A13
Bethesda, MD  20892-9155
Telephone:  (301) 496-4226
FAX:  (301) 480-1080
Email:  MM108W@nih.gov

Direct inquiries regarding fiscal matters to:

Jeff Carow
Grants Management Officer
National Institute of Nursing Research
Building 45, Room 3AN-12, MSC 6301
Bethesda, MD  20892-6301
Telephone:  (301) 594-6869
FAX:  (301) 480-8260
Email:  jcarow@ep.ninr.nih.gov

Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
Building 61E, Room 8A17
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
FAX:  (301) 402-0915
Email:  MC113B@nih.gov

Sharon Hunt
Grants Management Officer
National Institute of Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400B, MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-0909
Email:  Sharon_Hunt@NIH.GOV

Joseph Ellis
Grants Management Officer
National Institute on Aging
Gateway Building, Suite 2N212, MSC 9205
Bethesda  MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  ellisj@exmur.nia.nih.gov

Gladys Melendez-Bohler
Grants Management Branch
National Institute of Neurological Disorders and Stroke
Federal Building, Room 10-04
Bethesda, MD  20892
Telephone:  (301) 496-9231
FAX:  (301) 402-0219
Email:  GB13Y@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.361 and 93.866.  Awards are made under authorization of the Public Health
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-
158, 42 USC 241 and 285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-
free workplace and promote the non-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.

References

Agency for Health Care Policy and Research. (1995). Post-Stroke rehabilitation:
Assessment, referral, and patient management. Clinical Practice Guideline.
Rockville, MD: DHHS, PHS, AHCPR, Pub. No. 95-0662.

National Conference on Public Health and Epilepsy, Living Well with Epilepsy,
Centers for Disease Control and Prevention, Orlando, Florida, September 10-11,
1997.

National Institute of Child Health and Human Development (1993).  Research Plan
for the National Center for Medical Rehabilitation Research. Bethesda, MD: DHHS,
PHS, NIH, NICHD, Pub. No. 93-3509.


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