NIH Clinical Research Studies

Protocol Number: 03-N-0165

Active Accrual, Protocols Recruiting New Patients

Title:
Cortical Control of Postural Stability in the Elderly
Number:
03-N-0165
Summary:
This study will examine loss of balance in the elderly. Falls due to balance problems are a major health issue in older people, often resulting in bone fractures and other bodily injuries, and functional decline. In addition, the fear of falling leads some elderly people to restrict their movements and social activities, causing depressed moods and decreased enjoyment of life. Risk factors for falling in the elderly include some standing positions in which older people usually experience balance problems, such as leaning forward or backward. This study will examine these unstable positions and the brain mechanisms associated with loss of balance in the elderly.

Normal volunteers between 20 and 90 years of age may be eligible for this study. Candidates must be in good health, with no difficulties in performing activities of daily living, and must be able to walk for at least 400 meters (1/4 mile). They will be screened with a medical history, physical examination, and blood tests.

Participants will undergo the following three experiments:

- Movement task: The subject stands on a platform with markers placed at different parts of the body to record body movements. A cap with electrodes (metal disks) is placed on the head for electrocardiographic (EEG) recording of the electrical activity of the brain (brain waves) during the experiment. The positions of the feet on the platform are measured. While standing on the platform, the subject leans forward and backward as far as possible without losing balance. (Subjects are secured in a safety harness to prevent actual falls.) The task is repeated 5 times. The experiment lasts up to 2 hours.

- Postural response task: This study is identical to the first, except that the subject does not voluntarily lean forward and backward, but is pushed with a device to cause forward and backward movements. The experiment lasts 1 to 2 hours.

- Perceptual task: The subject sits in front of a computer screen and watches the postural movements of a human body model in forward and backward directions. When the subject recognizes an unstable position in the movements, he or she presses a computer mouse. An EEG records brain activity during the task, which lasts up to 2 hours.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

Subjects will be enrolled in this balance study if they are within the range of 20-90 years old;

in good health;

report no difficulties or need for help in performing self-care or instrumental activities of daily living;

and are able to walk for at least 400 meters.

EXCLUSION CRITERIA:

We will be unable to study people who have substantial congitive impairment based on mental status screening tests;

history of cardiovascular disease (including angina, myocardial infarction, congestive heart failure, cerebro-vascular disease);

cancer;

neurological diseases;

birth defects;

kidney or liver disease;

gastrointestinal (G.I.) disease;

musculo-skeletal disorder (if they cause pathological weakness and/or chronic pain);

important sensory deficits and any conditions that precludes them from being tested with standard neurophyschological tests.

Pregnant women will be excluded from this study.

In addition, the following criteria are considered as markers of pathological conditions and are used as exclusion criteria for study enrollment:

a) HIV virus infection;

b) WBC greater than 12,000 ML;

c) Platelets less than 100,000 or greater than 600,000/ML;

d) Hemoglobin less than 11 gr/dl unless higher level can be ascribed to Gilbert's disease;

e) Abnormal level of SGOT and SGPT and alkaline phosphetase twice the norm serum concentration;

f) Corrected calcium less than 8.5 or 10.7 mg/dl;

g) Albumin less than 3.4 g/dl;

h) Shortness of breath while performing normal activities of daily living, such as walking or climbing stairs;

i) evidence or history of cancer;

j) absolute need for long term treatment with antibiotics, corticosteroids, immunosuppressors, H2 blockers and pain medications;

k) any severe psychiatric condition such as subjects with Axis I psychiatric diagnosis;

l) any condition that may preclude informed consent.

Special Instructions: Currently Not Provided
Keywords:
Postural Stability
EEG
Aging
Falls
Recruitment Keywords:
Healthy Volunteer
HV
Conditions:
Musculoskeletal Physiology
Healthy
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Arfken CL, Lach HW, Birge SJ, Miller JP. The prevalence and correlates of fear of falling in elderly persons living in the community. Am J Public Health. 1994 Apr;84(4):565-70. PMID: 8154557

Dunn JE, Rudberg MA, Furner SE, Cassel CK. Mortality, disability, and falls in older persons: the role of underlying disease and disability. Am J Public Health. 1992 Mar;82(3):395-400. PMID: 1531583

Eeg-Olofsson O. Longitudinal developmental course of electrical activity of brain. Brain Dev. 1980;2(1):33-44. PMID: 7416440

Active Accrual, Protocols Recruiting New Patients

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