HealthyNCT00001844
Study of New Magnetic Resonance Methods
An observational study of Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will evaluate new magnetic resonance imaging (MRI ) methods using a MRI machine more powerful than those in most hospitals. MRI is a diagnostic tool that uses a large magnet and radio waves to produce images of the human body. It can also provide information about brain chemistry and physiology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 1999to 7 Sep 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 and older
- capable of providing own informed consent
- capable of filling out MRI screening form
Who cannot join
- contraindications for MRI including aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body (e.g. metal shavings); or insulin pump, or other metal in the body.
- pregnancy
- Subjects will be excluded if it is deemed that they have a condition that would preclude their participation for technical development (e.g. claustrophobia)
- Subjects will be excluded if they present unnecessary risk (e.g. Brain surgery of uncertain type, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Functional and Metabolic Imaging Using Magnetic Resonance at 3.0 Tesla
This study will evaluate new magnetic resonance imaging (MRI ) methods using a MRI machine more powerful than those in most hospitals. MRI is a diagnostic tool that uses a large magnet and radio waves to produce images of the human body. It can also provide information about brain chemistry and physiology. This study will use the new MRI hardware and methods to measure blood flow and metabolism in regions of the brain during simple tasks, such as listening to tones or watching flashing checkerboards.
Healthy normal volunteers will undergo MRI scanning. For this procedure, the person lies on a stretcher that is moved into a MRI machine, which produces a strong magnetic field. A special lightweight coil is placed on the person's head to obtain better pictures. The scan time ranges from 20 minutes to 2 hours, with the average scan lasting between 45 and 90 minutes.
Read more
During the MRI, the person may be asked to perform simple tasks, such as listening to tones or watching a screen, tapping fingers or moving a hand. More complex tasks may require thinking about tones or pictures and responding to them by pressing buttons.
The images produced in this study will be compared with those produced using standard MRI. The results will be used to develop improved imaging methods for better patient care and research.
Read the detailed description
Technical advances in Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) has provided researchers with the opportunity to study functional and metabolic changes of the central nervous system (CNS) in both healthy controls and individuals with neurological diseases in response to sensory, motor or cognitive stimulation. While MRI is in common usage in radiology departments and clinics MRI and MRS techniques and hardware are continually being upgraded and designed for Functional Magnetic Resonance Imaging (fMRI) and Magnetic Resonance Spectroscopic Imaging of the CNS at 3.0 Tesla. We will evaluate new sequences on volunteers and for potential use in patients with CNS pathology. These studies are required in order to develop and implement new imaging techniques for research and clinical applications.
- Conditions
- Healthy
- Keywords
- MRI/MRS, Functional MRI, Metabolic Imaging, Brain, Healthy Volunteer
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 start8 Sep 1999
- Study completion7 Sep 2012
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.
- 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Investigators
- Joseph A Frank, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001844
- Sponsor's protocol ID
- 990163
- Other IDs
- 99-CC-0163
- Status last verified
- 7 Sep 2012
- First submitted
- 3 Nov 1999
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Ogawa S, Lee TM, Kay AR, Tank DW. Brain magnetic resonance imaging with contrast dependent on blood oxygenation. Proc Natl Acad Sci U S A. 1990 Dec;87(24):9868-72. doi: 10.1073/pnas.87.24.9868.
PubMed 2124706Belliveau JW, Kennedy DN Jr, McKinstry RC, Buchbinder BR, Weisskoff RM, Cohen MS, Vevea JM, Brady TJ, Rosen BR. Functional mapping of the human visual cortex by magnetic resonance imaging. Science. 1991 Nov 1;254(5032):716-9. doi: 10.1126/science.1948051.
PubMed 1948051Turner R, Howseman A, Rees GE, Josephs O, Friston K. Functional magnetic resonance imaging of the human brain: data acquisition and analysis. Exp Brain Res. 1998 Nov;123(1-2):5-12. doi: 10.1007/s002210050538.
PubMed 9835386
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Metabolic Imaging Using Magnetic Resonance at 3.0 Tesla
- ClinicalTrials.gov ID
- NCT00001844
- Acronym / sponsor ID
- 990163
- Conditions
- Healthy
- Keywords
- MRI/MRS, Functional MRI, Metabolic Imaging, Brain, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 99 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 8 Sep 1999
- Study completion
- 7 Sep 2012
- 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 will evaluate new magnetic resonance imaging (MRI ) methods using a MRI machine more powerful than those in most hospitals. MRI is a diagnostic tool that uses a large magnet and radio waves to produce images of the human body. It can also provide information about brain chemistry and physiology. This study will use the new MRI hardware and methods to measure blood flow and metabolism in regions of the brain during simple tasks, such as listening to tones or watching flashing checkerboards.
Healthy normal volunteers will undergo MRI scanning. For this procedure, the person lies on a stretcher that is moved into a MRI machine, which produces a strong magnetic field. A special lightweight coil is placed on the person's head to obtain better pictures. The scan time ranges from 20 minutes to 2 hours, with the average scan lasting between 45 and 90 minutes.
During the MRI, the person may be asked to perform simple tasks, such as listening to tones or watching a screen, tapping fingers or moving a hand. More complex tasks may require thinking about tones or pictures and responding to them by pressing buttons.
The images produced in this study will be compared with those produced using standard MRI. The results will be used to develop improved imaging methods for better patient care and research.
Detailed description
Technical advances in Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) has provided researchers with the opportunity to study functional and metabolic changes of the central nervous system (CNS) in both healthy controls and individuals with neurological diseases in response to sensory, motor or cognitive stimulation. While MRI is in common usage in radiology departments and clinics MRI and MRS techniques and hardware are continually being upgraded and designed for Functional Magnetic Resonance Imaging (fMRI) and Magnetic Resonance Spectroscopic Imaging of the CNS at 3.0 Tesla. We will evaluate new sequences on volunteers and for potential use in patients with CNS pathology. These studies are required in order to develop and implement new imaging techniques for research and clinical applications.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (4 listed)
- contraindications for MRI including aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body (e.g. metal shavings); or insulin pump, or other metal in the body.
- pregnancy
- Subjects will be excluded if it is deemed that they have a condition that would preclude their participation for technical development (e.g. claustrophobia)
- Subjects will be excluded if they present unnecessary risk (e.g. Brain surgery of uncertain type, etc.).
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 was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 2124706Ogawa S, Lee TM, Kay AR, Tank DW. Brain magnetic resonance imaging with contrast dependent on blood oxygenation. Proc Natl Acad Sci U S A. 1990 Dec;87(24):9868-72. doi: 10.1073/pnas.87.24.9868.
- Background: PubMed 1948051Belliveau JW, Kennedy DN Jr, McKinstry RC, Buchbinder BR, Weisskoff RM, Cohen MS, Vevea JM, Brady TJ, Rosen BR. Functional mapping of the human visual cortex by magnetic resonance imaging. Science. 1991 Nov 1;254(5032):716-9. doi: 10.1126/science.1948051.
- Background: PubMed 9835386Turner R, Howseman A, Rees GE, Josephs O, Friston K. Functional magnetic resonance imaging of the human brain: data acquisition and analysis. Exp Brain Res. 1998 Nov;123(1-2):5-12. doi: 10.1007/s002210050538.
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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.
Joseph A Frank, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
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, run by National Institutes of Health Clinical Center (CC) 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 4 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: stopped early, as of the sponsor's last update on 17 Dec 2019. 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 was stopped early. Results are not available in the source record.
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 NCT00001844, 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 17 Dec 2019.