Healthy VolunteerNCT00004577
Study of New Magnetic Resonance Imaging Methods of the Brain
An observational study of Healthy Volunteer and Magnetic Resonance Imaging, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
The purpose of this investigation is to develop improved magnetic resonance imaging (MRI) techniques and hardware for studying brain function. MRI is a diagnostic tool that provides information about brain chemistry and physiology. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Magnetic Resonance Imaging, Healthy
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2000to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteer
Who may be able to join
- 18 years of age and older
- in good general health
- able to understand the procedures and requirements and give informed consent
Who cannot join
- All Subjects will undergo a neurological physical and answer the Healthy volunteer form, and the most-recent version of the NMR safety screening form
- A subject will be excluded if he/she:
- has any metal implant or objects of unknown identity or composition, or if it s known to be non-compatible with MRI, such as pacemakers, medication pumps, aneurysm clips, metallic prosthesis (such as heart valves or cochlear implants), certain orthopedic implants (pins and rods), shrapnel, or small metal fragments in the eye;
- has claustrophobia;
- cannot lie comfortably for up to 120 minutes;
- underwent brain surgery or suffered a traumatic head trauma;
Show all 17Show fewer
- has migraines that require medication;
- has ever been hospitalized for a psychiatric disorder;
- has medical health problems such as pulmonary or airway disease, heart failure, coronary artery disease, and uncontrolled hypertension which would require physiological monitoring during the scan;
- has a history of any medical condition that could result in an emergency medical situation while undergoing the MRI scan;
- has hearing problems which would make it difficult to tolerate scanner noise;
- is pregnant;
- has body/make-up tattoos (e.g. lips, eyebrows, eyeliner). Each tattoo will be considered on a case-to-case basis, taking into account of the age and location of the tattoo;
- has a sleep apnea diagnosis;
- has a neurological disorder, such as Stroke, Parkinson s, and Epilepsy;
- a member of the NINDS Laboratory of Functional and Molecular Imaging.
- The contraindications to MRI at the various field strengths are almost identical, except the 7 T also excludes subjects with gold dental crowns.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Characterization of Brain Morphology and Activity Using Functional and Anatomical MRI Contrast
The purpose of this investigation is to develop improved magnetic resonance imaging (MRI) techniques and hardware for studying brain function. MRI is a diagnostic tool that provides information about brain chemistry and physiology. This study will evaluate new MRI methods for monitoring blood flow to regions of the brain in response to simple tasks. The MRI machine used in this study is more powerful than those in most hospitals, permitting a higher visual resolution.
Normal healthy volunteers over 18 years old may be eligible for this study. Candidates will be screened with a medical history and questionnaire, and a neurological examination. Study participants will have a yearly MRI scan. For this procedure, the subject lies on a stretcher that is moved into a donut-shaped machine with a strong magnetic field. A lightweight circular or rectangular coil-a device that improves the quality of the images-may be placed on the head. The scan time varies from 20 minutes to 3 hours; most scans last between 45 and 90 minutes. During the scan, the subject may perform simple tasks, such as listening to tapes, tapping a finger, moving a hand, watching a screen, or smelling a fragrance. More complex tasks may require thinking about tones or pictures and responding to them by pressing buttons.
Read more
Information from this study will be used to develop better imaging methods that will, in turn, permit a greater understanding of normal and abnormal brain behaviors.
...
Read the detailed description
Objective
The goal of this protocol is to improve spatial resolution and contrast in MRI studies of brain anatomy and function, by developing novel hardware, and image acquisition and reconstruction techniques. Specifically, by improving MRI image quality and manipulating MRI contrast, we aim to better characterize and quantify structural, chemical, and blood flow variations across the brain, and study their relationship with neuronal activity. For this purpose, we will develop and optimize novel MRI techniques on normal, healthy volunteers, and combine these with EEG and recording of other physiological signals.
Study Population
Any healthy, male or female volunteer 18 years of age and older; the subjects must be capable of understanding the procedures and requirements of this study and be willing to sign an informed consent document.
Design
This is a technical development study design to develop and evaluate new MR technology for performing MRI and functional MRI in the CNS with novel contrasts and with a high spatial resolution.
Outcome Measures
The primary outcome of this study will be the ability to acquire anatomical and functional images of the human brain with high spatial resolution, i.e., 200-500 micron and 750-1000 micron respectively. In addition, developed techniques will allow the robust measurement of specific tissue properties, including diffusion, structural anisotropy, iron and myelin content, perfusion, and metabolite concentrations. The relative merits of blood flow and blood oxygenation level dependent (BOLD) functional MRI (fMRI) techniques, and their particular spatial and temporal signal characteristics will be established. It will be determined whether information valuable to interpret BOLD fMRI can be derived from EEG and other physiological signals.
- Conditions
- Healthy Volunteer, Magnetic Resonance Imaging, Healthy, fMRI, Brain Mapping, Adult
- Keywords
- Brain Morphology, Cerebral Blood Volume, Functional Imaging, Development, MEG, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Any healthy, male or female volunteer 18 years of age and older. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of this study is to develop and evaluate new MR pulse sequences and hardware for performing anatomical and functional MRI in the CNS at, 3.0T, and 7T with a high spatial resolution.
The primary outcome of this study will be the ability to robustly acquire whole brain MRI sensitized to myelin, iron, diffusion, perfusion, and fiber orientation. Perfusion- and BOLD- based fMRI techniques will allow distinguishing between neuronal and systemic vascular signal contributions. In addition, we anticipate the ability to acquire (proton) spectroscopic data at 5mm resolution.
Measured: annually
Secondary outcomes (1)
To develop an understanding of the limits in contrast and resolution of anatomical and functional MRI.To develop an understanding of the merits of high field MRI for the study of brain anatomy and function.
Secondary outcome measure will be an estimate of the relative performance levels of the different field strengths for anatomical, functional and spectroscopic imaging.
Measured: annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2000 (estimated)
- Study start1 Jul 2000
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 Healthy VolunteerStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Alan P Koretsky, Ph.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004577
- Sponsor's protocol ID
- 000082
- Other IDs
- 00-N-0082
- Status last verified
- 25 Aug 2026
- First submitted
- 18 Feb 2000
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 2124706Ogawa S, Tank DW, Menon R, Ellermann JM, Kim SG, Merkle H, Ugurbil K. Intrinsic signal changes accompanying sensory stimulation: functional brain mapping with magnetic resonance imaging. Proc Natl Acad Sci U S A. 1992 Jul 1;89(13):5951-5. doi: 10.1073/pnas.89.13.5951.
PubMed 1631079Detre JA, Leigh JS, Williams DS, Koretsky AP. Perfusion imaging. Magn Reson Med. 1992 Jan;23(1):37-45. doi: 10.1002/mrm.1910230106.
PubMed 1734182
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Brain Morphology and Activity Using Functional and Anatomical MRI Contrast
- ClinicalTrials.gov ID
- NCT00004577
- Acronym / sponsor ID
- 000082
- Conditions
- Healthy Volunteer, Magnetic Resonance Imaging, Healthy, fMRI, Brain Mapping, Adult
- Keywords
- Brain Morphology, Cerebral Blood Volume, Functional Imaging, Development, MEG, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 1 Jul 2000 (actual)
- First posted
- 21 Feb 2000 (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.
The purpose of this investigation is to develop improved magnetic resonance imaging (MRI) techniques and hardware for studying brain function. MRI is a diagnostic tool that provides information about brain chemistry and physiology. This study will evaluate new MRI methods for monitoring blood flow to regions of the brain in response to simple tasks. The MRI machine used in this study is more powerful than those in most hospitals, permitting a higher visual resolution.
Normal healthy volunteers over 18 years old may be eligible for this study. Candidates will be screened with a medical history and questionnaire, and a neurological examination. Study participants will have a yearly MRI scan. For this procedure, the subject lies on a stretcher that is moved into a donut-shaped machine with a strong magnetic field. A lightweight circular or rectangular coil-a device that improves the quality of the images-may be placed on the head. The scan time varies from 20 minutes to 3 hours; most scans last between 45 and 90 minutes. During the scan, the subject may perform simple tasks, such as listening to tapes, tapping a finger, moving a hand, watching a screen, or smelling a fragrance. More complex tasks may require thinking about tones or pictures and responding to them by pressing buttons.
Information from this study will be used to develop better imaging methods that will, in turn, permit a greater understanding of normal and abnormal brain behaviors.
...
Detailed description
Objective
The goal of this protocol is to improve spatial resolution and contrast in MRI studies of brain anatomy and function, by developing novel hardware, and image acquisition and reconstruction techniques. Specifically, by improving MRI image quality and manipulating MRI contrast, we aim to better characterize and quantify structural, chemical, and blood flow variations across the brain, and study their relationship with neuronal activity. For this purpose, we will develop and optimize novel MRI techniques on normal, healthy volunteers, and combine these with EEG and recording of other physiological signals.
Study Population
Any healthy, male or female volunteer 18 years of age and older; the subjects must be capable of understanding the procedures and requirements of this study and be willing to sign an informed consent document.
Design
This is a technical development study design to develop and evaluate new MR technology for performing MRI and functional MRI in the CNS with novel contrasts and with a high spatial resolution.
Outcome Measures
The primary outcome of this study will be the ability to acquire anatomical and functional images of the human brain with high spatial resolution, i.e., 200-500 micron and 750-1000 micron respectively. In addition, developed techniques will allow the robust measurement of specific tissue properties, including diffusion, structural anisotropy, iron and myelin content, perfusion, and metabolite concentrations. The relative merits of blood flow and blood oxygenation level dependent (BOLD) functional MRI (fMRI) techniques, and their particular spatial and temporal signal characteristics will be established. It will be determined whether information valuable to interpret BOLD fMRI can be derived from EEG and other physiological signals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | –Any healthy, male or female volunteer 18 years of age and older. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteer
Key inclusion criteria (3 listed)
- 18 years of age and older
- in good general health
- able to understand the procedures and requirements and give informed consent
Key exclusion criteria (17 listed)
- All Subjects will undergo a neurological physical and answer the Healthy volunteer form, and the most-recent version of the NMR safety screening form
- has any metal implant or objects of unknown identity or composition, or if it s known to be non-compatible with MRI, such as pacemakers, medication pumps, aneurysm clips, metallic prosthesis (such as heart valves or cochlear implants), certain orthopedic implants (pins and rods), shrapnel, or small metal fragments in the eye;
- has claustrophobia;
- cannot lie comfortably for up to 120 minutes;
- underwent brain surgery or suffered a traumatic head trauma;
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
The purpose of this study is to develop and evaluate new MR pulse sequences and hardware for performing anatomical and functional MRI in the CNS at, 3.0T, and 7T with a high spatial resolution.
Time frame: annually
The primary outcome of this study will be the ability to robustly acquire whole brain MRI sensitized to myelin, iron, diffusion, perfusion, and fiber orientation. Perfusion- and BOLD- based fMRI techniques will allow distinguishing between neuronal and systemic vascular signal contributions. In addition, we anticipate the ability to acquire (proton) spectroscopic data at 5mm resolution.
1 secondary outcome
To develop an understanding of the limits in contrast and resolution of anatomical and functional MRI.To develop an understanding of the merits of high field MRI for the study of brain anatomy and function.
Time frame: annually
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- 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 1631079Ogawa S, Tank DW, Menon R, Ellermann JM, Kim SG, Merkle H, Ugurbil K. Intrinsic signal changes accompanying sensory stimulation: functional brain mapping with magnetic resonance imaging. Proc Natl Acad Sci U S A. 1992 Jul 1;89(13):5951-5. doi: 10.1073/pnas.89.13.5951.
- Background: PubMed 1734182Detre JA, Leigh JS, Williams DS, Koretsky AP. Perfusion imaging. Magn Reson Med. 1992 Jan;23(1):37-45. doi: 10.1002/mrm.1910230106.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Alan P Koretsky, Ph.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Volunteer and Magnetic Resonance Imaging, 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 17 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey H Duyn, Ph.D. ((301) 594-7305, duynjeff@ninds.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The purpose of this study is to develop and evaluate new MR pulse sequences and hardware for performing anatomical and functional MRI in the CNS at, 3.0T, and 7T with a high spatial resolution. (time frame: annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004577, 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 29 Oct 2026.