AmnesiaNCT00001362
Magnetic Resonance Imaging for the Study of Patients With Neurological Disorders
An observational study of Amnesia and Dementia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study is divided into two parts. The first part of the study will use MRI technology to view the brain structure of patients with neurological disorders and normal volunteers. This portion of the study will attempt to detect specific areas of damage in the brains of patients with amnesia and dementia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- How many people
- 830 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1992to Jul 2003
- 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
- Subjects between the ages of 18 and 80.
Who cannot join
- Patient must be able to give informed consent.
- Patients with ferromagnetic objects in their bodies which might be adversely affected by MRI (surgical clips or metal fragments in or near brain, eye or blood vessels, cardiac or neurological pacemaker, cochlear impairments) will be excluded.
- Pregnant or lactating women will be excluded. A pregnancy test will be administered to women of childbearing age.
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: Structural and Functional Imaging of Neurologically Impaired Patients and Normal Volunteers With 1.5 and 3.0 Tesla MRI
This study is divided into two parts. The first part of the study will use MRI technology to view the brain structure of patients with neurological disorders and normal volunteers. This portion of the study will attempt to detect specific areas of damage in the brains of patients with amnesia and dementia. It will also try to correlate the amount of brain damage with performance on tests used to measure memory.
In the second part of the study, researchers plan to use MRI technology to study brain function of patients with neurological disorders and normal volunteers when they perform tasks. MRI signals during task performance will be used to record areas of the brain receiving more blood flow indicating increased activity.
Researchers believe this study will help improve existing methods of evaluating patients with neurological disorders. In addition, this study may contribute information about areas of the brain involved in thought processing and motor and sensory function.
Read the detailed description
We wish to use MRI technology to study brain structure (Part 1) and function (Part 2) in several neurological disorders and in normal controls. In Part 1 of this protocol, we describe our interest in using detailed MRI brain structure analysis to identify predicted specific neural structure atrophy in patients with selective amnesia and dementia and to attempt to associate the magnitude of atrophy in these neural structures with performance on selected memory tests. In Part 2 of this protocol, we outline our interest in utilizing newly developed MRI techniques to identify selective changes in local brain blood volume, blood flow, and other physiological parameters during functional stimulation. Recent developments permit recording of MRI signals that are indicative of regional cerebral blood volume and blood flow changes. Local changes in these physiological measures appear to topographically overlap with expected areas of functional brain activation. The advantage of this method over Positron Emission Tomography is the exquisite spatial resolution of MRI. This MRI technique is new and has had only limited use so far. The studies in Part 2 of this protocol should help develop the method and begin to answer fundamental biological and functional questions about the representation and activation of cognitive, motor, and sensory functions.
- Conditions
- Amnesia, Dementia, Healthy, Nervous System Disease
- Keywords
- Magnetic Resonance Imaging, Contrast Enhancement, Neuroanatomic Morphometry, Neurobehavioral Deficits, Neurological Disorders, Blood Flow, Blood Volume, Normal Volunteer
- Medical subject headings
- Amnesia, Dementia, Nervous System Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startDec 1992
- Study completionJul 2003
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 AmnesiaStudies 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
- 830 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001362
- Sponsor's protocol ID
- 930060
- Other IDs
- 93-N-0060
- Status last verified
- Jul 2003
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Rueckert L, Lange N, Partiot A, Appollonio I, Litvan I, Le Bihan D, Grafman J. Visualizing cortical activation during mental calculation with functional MRI. Neuroimage. 1996 Apr;3(2):97-103. doi: 10.1006/nimg.1996.0011.
PubMed 9345480Rueckert L, Appollonio I, Grafman J, Jezzard P, Johnson R Jr, Le Bihan D, Turner R. Magnetic resonance imaging functional activation of left frontal cortex during covert word production. J Neuroimaging. 1994 Apr;4(2):67-70. doi: 10.1111/jon19944267.
PubMed 8186531Levin HS, Scheller J, Rickard T, Grafman J, Martinkowski K, Winslow M, Mirvis S. Dyscalculia and dyslexia after right hemisphere injury in infancy. Arch Neurol. 1996 Jan;53(1):88-96. doi: 10.1001/archneur.1996.00550010108024.
PubMed 8599565
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
- Structural and Functional Imaging of Neurologically Impaired Patients and Normal Volunteers With 1.5 and 3.0 Tesla MRI
- ClinicalTrials.gov ID
- NCT00001362
- Acronym / sponsor ID
- 930060
- Conditions
- Amnesia, Dementia, Healthy, Nervous System Disease
- Keywords
- Magnetic Resonance Imaging, Contrast Enhancement, Neuroanatomic Morphometry, Neurobehavioral Deficits, Neurological Disorders, Blood Flow, Blood Volume, Normal Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 830 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Dec 1992
- Study completion
- Jul 2003
- First posted
- 4 Nov 1999 (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 is divided into two parts. The first part of the study will use MRI technology to view the brain structure of patients with neurological disorders and normal volunteers. This portion of the study will attempt to detect specific areas of damage in the brains of patients with amnesia and dementia. It will also try to correlate the amount of brain damage with performance on tests used to measure memory.
In the second part of the study, researchers plan to use MRI technology to study brain function of patients with neurological disorders and normal volunteers when they perform tasks. MRI signals during task performance will be used to record areas of the brain receiving more blood flow indicating increased activity.
Researchers believe this study will help improve existing methods of evaluating patients with neurological disorders. In addition, this study may contribute information about areas of the brain involved in thought processing and motor and sensory function.
Detailed description
We wish to use MRI technology to study brain structure (Part 1) and function (Part 2) in several neurological disorders and in normal controls. In Part 1 of this protocol, we describe our interest in using detailed MRI brain structure analysis to identify predicted specific neural structure atrophy in patients with selective amnesia and dementia and to attempt to associate the magnitude of atrophy in these neural structures with performance on selected memory tests. In Part 2 of this protocol, we outline our interest in utilizing newly developed MRI techniques to identify selective changes in local brain blood volume, blood flow, and other physiological parameters during functional stimulation. Recent developments permit recording of MRI signals that are indicative of regional cerebral blood volume and blood flow changes. Local changes in these physiological measures appear to topographically overlap with expected areas of functional brain activation. The advantage of this method over Positron Emission Tomography is the exquisite spatial resolution of MRI. This MRI technique is new and has had only limited use so far. The studies in Part 2 of this protocol should help develop the method and begin to answer fundamental biological and functional questions about the representation and activation of cognitive, motor, and sensory functions.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects between the ages of 18 and 80.
Key exclusion criteria (3 listed)
- Patient must be able to give informed consent.
- Patients with ferromagnetic objects in their bodies which might be adversely affected by MRI (surgical clips or metal fragments in or near brain, eye or blood vessels, cardiac or neurological pacemaker, cochlear impairments) will be excluded.
- Pregnant or lactating women will be excluded. A pregnancy test will be administered to women of childbearing age.
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 9345480Rueckert L, Lange N, Partiot A, Appollonio I, Litvan I, Le Bihan D, Grafman J. Visualizing cortical activation during mental calculation with functional MRI. Neuroimage. 1996 Apr;3(2):97-103. doi: 10.1006/nimg.1996.0011.
- Background: PubMed 8186531Rueckert L, Appollonio I, Grafman J, Jezzard P, Johnson R Jr, Le Bihan D, Turner R. Magnetic resonance imaging functional activation of left frontal cortex during covert word production. J Neuroimaging. 1994 Apr;4(2):67-70. doi: 10.1111/jon19944267.
- Background: PubMed 8599565Levin HS, Scheller J, Rickard T, Grafman J, Martinkowski K, Winslow M, Mirvis S. Dyscalculia and dyslexia after right hemisphere injury in infancy. Arch Neurol. 1996 Jan;53(1):88-96. doi: 10.1001/archneur.1996.00550010108024.
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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 Amnesia and Dementia, 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 1 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 NCT00001362, 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.