NCT00004577

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2000

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2000

Completed
Last Updated

April 14, 2026

Status Verified

March 6, 2026

First QC Date

February 18, 2000

Last Update Submit

April 11, 2026

Conditions

Keywords

Brain MorphologyCerebral Blood VolumeFunctional ImagingDevelopmentMEGNatural History

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    annually

Study Arms (1)

Healthy Volunteer

Any healthy, male or female volunteer 18 years of age and older.

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Volunteer

You may qualify if:

  • years of age and older
  • in good general health
  • able to understand the procedures and requirements and give informed consent

You may not qualify if:

  • 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;
  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 2124706BACKGROUND
  • Ogawa 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.

    PMID: 1631079BACKGROUND
  • Detre JA, Leigh JS, Williams DS, Koretsky AP. Perfusion imaging. Magn Reson Med. 1992 Jan;23(1):37-45. doi: 10.1002/mrm.1910230106.

    PMID: 1734182BACKGROUND

Related Links

Study Officials

  • Alan P Koretsky, Ph.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey H Duyn, Ph.D.

CONTACT

Alan P Koretsky, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2000

First Posted

February 21, 2000

Study Start

July 1, 2000

Last Updated

April 14, 2026

Record last verified: 2026-03-06

Data Sharing

IPD Sharing
Will not share

Locations