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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Buonocore, MD, PhD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00593931
First received: January 3, 2008
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Diagnosis, Psychiatric
 Other: fMRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Development Of New Techniques For Functional Magnetic Resonance Imaging Of The Brain

Resource links provided by NLM:

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

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • transient changes in blood flow in the brain that occurs with neuronal activity [ Time Frame: Post-scanning ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity to blood oxygenation versus blood flow versus blood volume contrast mechanisms [ Time Frame: Post-scanning ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: May 1999
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Normal Subjects
 Other: fMRI
Functional Magnetic Resonance Imaging without contrast

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593931

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

No publications provided

Responsible Party: Michael Buonocore, MD, PhD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00593931     History of Changes
Other Study ID Numbers: 200210591
Study First Received: January 3, 2008
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013