NCT00056914

Brief Summary

This study will develop new techniques for optimizing resolution in magnetic resonance imaging (MRI) with a high magnetic field of 7 Tesla. MRI is a diagnostic tool that generates high-quality images of the body without the use of x-rays. It can also provide information about brain chemistry and physiology. The test is routinely done at magnetic field strengths of from 1.5 to 4 Tesla. This study will use an investigational device that operates at a high magnetic field of 7 Tesla. Except for the increase in magnetic field, all other aspects of imaging are the same as those at lower magnetic fields. This study will use techniques in conjunction with the higher magnetic field that may improve diagnostic imaging. The MRI will monitor the brain at high resolution to see structural features, to measure brain chemicals, and to determine how much and how fast blood flows into brain regions in response to simple tasks. Healthy normal volunteers 18 years of age and older may participate in this study. Candidates will be screened with a medical history, neurological examination, and questionnaire. Participants will have a standard 1.5 or 3 Tesla MRI before the 7 Tesla scan, adding about 5 minutes to the procedure. The procedure for both scans is the same. The subject lies on a table that is moved into the scanner. Because the machine makes loud sounds during the imaging, earplugs are provided to help reduce the noise. An insulated wire coil may be placed around the subject's head to obtain better images. Scanning time varies from 20 minutes to 3 hours, with most examinations lasting between 45 and 90 minutes. During the scan, the subject may be asked to perform simple tasks, such as listening to tones, tapping fingers, moving a hand, watching a movie on a screen, or smelling pleasant odors. More complex tasks may require thinking about tones or pictures and responding to them by pressing buttons. Following the test, subjects will complete a brief questionnaire about comfort level and any unusual sensations they may have experienced during the test. Participants who undergo repeated MRIs for the evaluation of new techniques will have a standard 1.5 or 3 Tesla MRI brain study once a year while participating in the research protocol. A radiologist at NIH will read the MRIs, and if any abnormalities are discovered, the individual will be referred to his or her private physician or to a consult service at NIH. ...

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 21, 2003

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2003

Completed
Same day until next milestone

First Posted

Study publicly available on registry

March 26, 2003

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2010

Completed
Last Updated

July 2, 2017

Status Verified

January 5, 2010

First QC Date

March 26, 2003

Last Update Submit

June 30, 2017

Conditions

Keywords

Magnetic Resonance ImagingFunctional ImagingCerebral Blood FlowParallel ImagingBOLD EffectSpectroscopic ImagingHealthy VolunteerHV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Only neurologically and psychiatrically normal, male or female, healthy volunteers over 18 years old will be used in these studies. Subjects must be capable of understanding the procedures and requirements of this study. Subjects must be willing to sign an informed consent document.

You may not qualify if:

  • A subject will be excluded if he/she has a contraindication to MR scanning such as the following: pregnancy, aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body (e.g. metal shavings or insulin pump), dental work such as crowns or bridges with indeterminate metals, pre-existing eye conditions, and any pre-existing hearing problems. Subjects who underwent brain surgery, who have a neurological lesion, a psychiatric history or a history of migraine will also be excluded from this study. The contraindications for MRI at 7T are identical to those at 1.5T and 3T.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Robitaille PM, Abduljalil AM, Kangarlu A, Zhang X, Yu Y, Burgess R, Bair S, Noa P, Yang L, Zhu H, Palmer B, Jiang Z, Chakeres DM, Spigos D. Human magnetic resonance imaging at 8 T. NMR Biomed. 1998 Oct;11(6):263-5. doi: 10.1002/(sici)1099-1492(199810)11:63.0.co;2-0.

    PMID: 9802467BACKGROUND
  • Abduljalil AM, Kangarlu A, Zhang X, Burgess RE, Robitaille PM. Acquisition of human multislice MR images at 8 Tesla. J Comput Assist Tomogr. 1999 May-Jun;23(3):335-40. doi: 10.1097/00004728-199905000-00001.

    PMID: 10348433BACKGROUND
  • Burgess RE, Yu Y, Abduljalil AM, Kangarlu A, Robitaille PM. High signal-to-noise FLASH imaging at 8 Tesla. Magn Reson Imaging. 1999 Oct;17(8):1099-103. doi: 10.1016/s0730-725x(99)00072-7.

    PMID: 10499671BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

March 26, 2003

First Posted

March 26, 2003

Study Start

March 21, 2003

Study Completion

January 5, 2010

Last Updated

July 2, 2017

Record last verified: 2010-01-05

Locations