HealthyNCT00060593
MRI Study of Self-Perception of Postural Stability
An observational study of Healthy and Postural Stability, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Postural Stability
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to May 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the detailed description
A number of studies have explored the role of visual, vestibular and somatosensory systems in the control of upright posture. However, the cortical control of postural stability, in general, and the role of higher cognitive function in assessment of postural stability, in specific, has not been studied extensively. It is well established that certain features of postural control change during the advancing years of life so that the stability of posture can be a problem in the elderly. However, neural mechanisms of postural stability that decline with age and make older adults more prone to falling have not been identified specifically. To characterize specific causes of falling in the elderly is problematic, because human posture is a product of an extremely complex dynamical system and like any other physical activity undergoes dramatic changes in organization throughout the life-span. In our previous research we showed the neural activation patterns embodied in the electroencephalogram (EEG) were associated with recognition of unstable postures in young healthy subjects. In another protocol, we propose that these patterns will systematically change with aging, and will result in difficulty to discriminate relevant from irrelevant information in the control of upright posture. The present study focuses on the evaluation of neural activation patterns underlying recognition of unstable postures in 15 young controls and 15 elderly subjects using both the block and event-related functional MRI (fMRI) designs. We will first analyze how the frontal-parieto-occipital circuits play a role in perception of postural stability in young subjects and then perform similar studies using elderly subjects. After the fMRI measurements a detailed evaluation of the haemodynamic response (BOLD) signals will be performed. Further analysis will look at the functional connectivity between the motion-selective cortical area (V5), the posterior parietal cortex (PP) and the frontal cortex (FC), using correlation methods. It is expected that from the study will uncover important insights in neural mechanisms as it relates to the self-perception of postural stability and its deterioration as a result of aging.
- Conditions
- Healthy, Postural Stability
- Keywords
- Balance, Functional Connectivity, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2003 (estimated)
- Study startMay 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 40 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060593
- Sponsor's protocol ID
- 030183
- Other IDs
- 03-N-0183
- Status last verified
- May 2005
- First submitted
- 7 May 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
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.
PubMed 8154557Bandettini 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.
PubMed 8366797Basar 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.
PubMed 7550619
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Perception of Postural Stability: Event-Related fMRI Study
- ClinicalTrials.gov ID
- NCT00060593
- Acronym / sponsor ID
- 030183
- Conditions
- Healthy, Postural Stability
- Keywords
- Balance, Functional Connectivity, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- May 2003
- Study completion
- May 2005
- First posted
- 8 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A number of studies have explored the role of visual, vestibular and somatosensory systems in the control of upright posture. However, the cortical control of postural stability, in general, and the role of higher cognitive function in assessment of postural stability, in specific, has not been studied extensively. It is well established that certain features of postural control change during the advancing years of life so that the stability of posture can be a problem in the elderly. However, neural mechanisms of postural stability that decline with age and make older adults more prone to falling have not been identified specifically. To characterize specific causes of falling in the elderly is problematic, because human posture is a product of an extremely complex dynamical system and like any other physical activity undergoes dramatic changes in organization throughout the life-span. In our previous research we showed the neural activation patterns embodied in the electroencephalogram (EEG) were associated with recognition of unstable postures in young healthy subjects. In another protocol, we propose that these patterns will systematically change with aging, and will result in difficulty to discriminate relevant from irrelevant information in the control of upright posture. The present study focuses on the evaluation of neural activation patterns underlying recognition of unstable postures in 15 young controls and 15 elderly subjects using both the block and event-related functional MRI (fMRI) designs. We will first analyze how the frontal-parieto-occipital circuits play a role in perception of postural stability in young subjects and then perform similar studies using elderly subjects. After the fMRI measurements a detailed evaluation of the haemodynamic response (BOLD) signals will be performed. Further analysis will look at the functional connectivity between the motion-selective cortical area (V5), the posterior parietal cortex (PP) and the frontal cortex (FC), using correlation methods. It is expected that from the study will uncover important insights in neural mechanisms as it relates to the self-perception of postural stability and its deterioration as a result of aging.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8154557Arfken 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.
- Background: PubMed 8366797Bandettini 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.
- Background: PubMed 7550619Basar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Postural Stability, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00060593, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.