Development Of New Techniques For Functional Magnetic Resonance Imaging Of The Brain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00593931
Recruitment Status : Terminated (Principal Investigator is deceased)
First Posted : January 15, 2008
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
This Protocol is intended to facilitate development and testing of new techniques for functional MRI by UC Davis Research Faculty, as well as to facilitate the evaluation of new techniques provided by the system manufacturers (GE and Siemens).

Condition or disease Intervention/treatment Phase
Diagnosis, Psychiatric Other: fMRI Not Applicable

Detailed Description:

New techniques covering a wide range of clinical and scientific applications will be developed, tested and evaluated. These include 1. Investigation of sensory stimulus processing and cognitive processing, both in normal subjects and patients with psychiatric disorders, 2. Early detection of stroke and other ischemic injury, and 3. Characterization of tumor distribution and activity. The new techniques will routinely need to be tested with respect to the following: 1. Sensitivity to blood oxygenation versus blood flow versus blood volume contrast mechanisms, 2. Signal-to-noise and contrast-to-noise ratio, 3. Spatial and temporal resolution, 4. Distribution and severity of image artifacts, and 5. Duty cycle limitations. Most clinical applications will require coverage of the entire brain and consequently high duty cycle operation, which needs to be traded off with spatial and temporal resolution, as well as contrast mechanisms. The work will also involve the testing of different experimental paradigms (time sequence of stimuli or cognitive tasks) to identify that which provides the highest signal change associated with the specific brain activity of interest.

Although 3T provides twice the signal of 1.5T systems, for some research applications this image quality advantage of 3T may be outweighed by other effects of higher field on the signal. Consequently, most new techniques will be evaluated on both the 1.5T and 3T systems, and a decision will be made based upon the overall image quality, regarding which system is to be used.

The Protocol does not involve injection of any contrast agent or drug, or other minimally-invasive or invasive procedure. It is intended specifically for those studies in which the subject is required, in addition to trying to relax and lie still, only to experience and respond to various non-harmful sensory stimuli, or to perform common cognitive (e.g. math calculations) and or motor (e.g. finger tapping) tasks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development Of New Techniques For Functional Magnetic Resonance Imaging Of The Brain
Study Start Date : May 1999
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Normal Subjects
Other: fMRI
Functional Magnetic Resonance Imaging without contrast

Primary Outcome Measures :
  1. transient changes in blood flow in the brain that occurs with neuronal activity [ Time Frame: Post-scanning ]

Secondary Outcome Measures :
  1. Sensitivity to blood oxygenation versus blood flow versus blood volume contrast mechanisms [ Time Frame: Post-scanning ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18 years of age or older
  • ability to give informed, written consent
  • Not pregnant or breastfeeding

Exclusion Criteria:

  • Electrically, magnetically, or mechanically activated implants (for example, cardiac-pacemakers)
  • Ferromagnetic implant, such as an aneurysm clip, surgical clip, or prosthesis
  • History of uncontrolled claustrophobia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00593931

Sponsors and Collaborators
University of California, Davis
Principal Investigator: Michael H Buonocore, M.D., Ph.D. UC Davis Dept. of Radiology

Responsible Party: University of California, Davis Identifier: NCT00593931     History of Changes
Other Study ID Numbers: 200210591
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University of California, Davis:
Brain functional MRI

Additional relevant MeSH terms:
Mental Disorders