- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00060593
MRI Study of Self-Perception of Postural Stability
Self-Perception of Postural Stability: Event-Related fMRI Study
This study will use functional magnetic resonance imaging (MRI) to 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 in functional decline. Risk factors for falling in the elderly include some standing positions in which older people usually experience balance problems, such as leaning forwards or backwards. Functional MRI records brain function while the subject performs a task, such as moving a limb or speaking, and detects changes in the brain regions involved in those tasks. This study will look at different brain areas to see which areas might control what people see around them while they are standing.
Healthy normal volunteers between 20 and 90 years of age may be eligible for this study. Candidates must be in good health, have no difficulties in performing activities of daily living, and be able to walk for at least 400 meters (1/4 mile). They will be screened with a medical history and physical examination.
Participants will undergo functional MRI while performing visual recognition tasks in two experiments, described below. For the MRI procedure, the subject lies in the MRI scanner, a narrow metal cylinder containing a strong magnet, for 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. The experiments are as follows:
Experiment 1
During MRI scanning, the subject watches computer-generated movies of a person leaning forwards and backwards. When the subject recognizes an unstable body position in the movements, he or she presses a computer mouse.
Experiment 2
During MRI scanning, the subject watches still pictures of people leaning in stable and unstable postures and presses a button as soon as he or she recognizes that the posture is unstable.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
There will be 20 subjects in each aforementioned age group.
Subjects will be enrolled in this study if they are within the range of 20-50 (young group) and 70-90 (old group) years old, in good health, report no difficulties or need for help in performing self-care or instrumental activities of daily living, are able to walk for at least 400 meters.
All subjects and patients participating in this study will have a valid Clinical Center Medical Record Number.
EXCLUSION CRITERIA:
We will be unable to study people who have substantial cognitive 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 neuropsychological tests.
MRI experiments will not be performed in subjects or patients who have pacemakers, brain stimulators, dental implants or metallic braces, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, insulin pump, or shrapnel fragments.
We will not scan pregnant women because of the safety of high magnetic fields to the fetus is not established.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- 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. doi: 10.2105/ajph.84.4.565.
- Bandettini PA, Jesmanowicz A, Wong EC, Hyde JS. Processing strategies for time-course data sets in functional MRI of the human brain. Magn Reson Med. 1993 Aug;30(2):161-73. doi: 10.1002/mrm.1910300204.
- Basar E, Demiralp T. Fast rhythms in the hippocampus are a part of the diffuse gamma-response system. Hippocampus. 1995;5(3):240-1. doi: 10.1002/hipo.450050311. No abstract available.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 030183
- 03-N-0183
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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