HealthyNCT00001591
Functional and Metabolic Imaging Using Magnetic Resonance Imaging and Spectroscopy
An observational study of Healthy and Nervous System Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Technical advances in magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) have provided researchers with the opportunity to study changes of the central nervous system (CNS) and improve diagnosis and therapy of CNS disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Nervous System Disease
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1997to 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
- Any normal volunteer age 18 and over who is capable of giving informed consent.
- For the purposes of evaluating new techniques for fMRI, patients will be considered the same as volunteers.
Who cannot join
- A subject will be excluded if he/she has a contraindication to MR scanning such as the following: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular foreign body or implant (e.g., metal shavings, retinal clips); breast implants or Insulin pump.
- Subjects who have a history of a reaction to MR contrast agents specifically gadopentetate dimeglumine will be excluded from participating in the contrast agent administration part of this protocol. The contraindications to MRI at 1.5 Tesla and 4 Tesla are identical.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Technical advances in magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) have provided researchers with the opportunity to study changes of the central nervous system (CNS) and improve diagnosis and therapy of CNS disease. New MRI and MRS techniques specifically designed for functional MRI (fMRI) and MRS imaging of the CNS will be evaluated in normal volunteers and in patients with CNS diseases. This study will develop and evaluate new magnetic resonance pulse sequences for performing MRI or MRS and compare the results to existing MR techniques.
Patients and volunteers age 18 and older are eligible for the study. A history will be taken in which exclusion criteria (such as having a pacemaker or cochlear implants) will be addressed, and a pregnancy test will be administered to women of childbearing age. Each subject will also be asked to fill out a questionnaire.
Study participants will lie in the MRI scanner from 20 minutes to 2 hours. A coil may be placed on the head and participants may be asked to do simple or complex tasks. A catheter will be placed in an arm vein and a contrast agent will be administered. This agent will allow structures in the brain to show up more clearly.
Read the detailed description
Technical advances in Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) have provided researchers with the opportunity to study functional and metabolic changes of the central nervous system (CNS) in both normal individuals and individuals with neurological diseases in response to sensory, motor or cognitive stimulation. New MRI and MRS techniques specifically designed for Functional Magnetic Resonance Imaging (fMRI) and Magnetic Resonance Spectroscopic Imaging of the CNS will be evaluated at 1.5 and/or at 4.0 Tesla on normal volunteers and in patients with CNS pathology.
- Conditions
- Healthy, Nervous System Disease
- Keywords
- Central Nervous System, Technical Development, Activation Studies, Pulse Sequences, Metabolites, Normal Volunteer
- Medical subject headings
- 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 startJul 1997
- 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 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
- 450 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001591
- Sponsor's protocol ID
- 970152
- Other IDs
- 97-CC-0152
- Status last verified
- Jul 2003
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Mattay VS, Frank JA, Santha AK, Pekar JJ, Duyn JH, McLaughlin AC, Weinberger DR. Whole-brain functional mapping with isotropic MR imaging. Radiology. 1996 Nov;201(2):399-404. doi: 10.1148/radiology.201.2.8888231.
PubMed 8888231Duyn JH, Yang Y, Frank JA, Mattay VS, Hou L. Functional magnetic resonance neuroimaging data acquisition techniques. Neuroimage. 1996 Dec;4(3 Pt 3):S76-83. doi: 10.1006/nimg.1996.0057.
PubMed 9345531Sorensen AG, Tievsky AL, Ostergaard L, Weisskoff RM, Rosen BR. Contrast agents in functional MR imaging. J Magn Reson Imaging. 1997 Jan-Feb;7(1):47-55. doi: 10.1002/jmri.1880070108.
PubMed 9039593
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
- Functional and Metabolic Imaging Using Magnetic Resonance Imaging and Spectroscopy
- ClinicalTrials.gov ID
- NCT00001591
- Acronym / sponsor ID
- 970152
- Conditions
- Healthy, Nervous System Disease
- Keywords
- Central Nervous System, Technical Development, Activation Studies, Pulse Sequences, Metabolites, Normal Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Jul 1997
- 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.
Technical advances in magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) have provided researchers with the opportunity to study changes of the central nervous system (CNS) and improve diagnosis and therapy of CNS disease. New MRI and MRS techniques specifically designed for functional MRI (fMRI) and MRS imaging of the CNS will be evaluated in normal volunteers and in patients with CNS diseases. This study will develop and evaluate new magnetic resonance pulse sequences for performing MRI or MRS and compare the results to existing MR techniques.
Patients and volunteers age 18 and older are eligible for the study. A history will be taken in which exclusion criteria (such as having a pacemaker or cochlear implants) will be addressed, and a pregnancy test will be administered to women of childbearing age. Each subject will also be asked to fill out a questionnaire.
Study participants will lie in the MRI scanner from 20 minutes to 2 hours. A coil may be placed on the head and participants may be asked to do simple or complex tasks. A catheter will be placed in an arm vein and a contrast agent will be administered. This agent will allow structures in the brain to show up more clearly.
Detailed description
Technical advances in Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) have provided researchers with the opportunity to study functional and metabolic changes of the central nervous system (CNS) in both normal individuals and individuals with neurological diseases in response to sensory, motor or cognitive stimulation. New MRI and MRS techniques specifically designed for Functional Magnetic Resonance Imaging (fMRI) and Magnetic Resonance Spectroscopic Imaging of the CNS will be evaluated at 1.5 and/or at 4.0 Tesla on normal volunteers and in patients with CNS pathology.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Any normal volunteer age 18 and over who is capable of giving informed consent.
- For the purposes of evaluating new techniques for fMRI, patients will be considered the same as volunteers.
Key exclusion criteria (2 listed)
- A subject will be excluded if he/she has a contraindication to MR scanning such as the following: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular foreign body or implant (e.g., metal shavings, retinal clips); breast implants or Insulin pump.
- Subjects who have a history of a reaction to MR contrast agents specifically gadopentetate dimeglumine will be excluded from participating in the contrast agent administration part of this protocol. The contraindications to MRI at 1.5 Tesla and 4 Tesla are identical.
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 8888231Mattay VS, Frank JA, Santha AK, Pekar JJ, Duyn JH, McLaughlin AC, Weinberger DR. Whole-brain functional mapping with isotropic MR imaging. Radiology. 1996 Nov;201(2):399-404. doi: 10.1148/radiology.201.2.8888231.
- Background: PubMed 9345531Duyn JH, Yang Y, Frank JA, Mattay VS, Hou L. Functional magnetic resonance neuroimaging data acquisition techniques. Neuroimage. 1996 Dec;4(3 Pt 3):S76-83. doi: 10.1006/nimg.1996.0057.
- Background: PubMed 9039593Sorensen AG, Tievsky AL, Ostergaard L, Weisskoff RM, Rosen BR. Contrast agents in functional MR imaging. J Magn Reson Imaging. 1997 Jan-Feb;7(1):47-55. doi: 10.1002/jmri.1880070108.
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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 Nervous System Disease, 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 2 inclusion and 2 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 NCT00001591, 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.