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

May 25, 2017 updated by: University of California, Davis
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

215

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
transient changes in blood flow in the brain that occurs with neuronal activity
Time Frame: Post-scanning
Post-scanning

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitivity to blood oxygenation versus blood flow versus blood volume contrast mechanisms
Time Frame: Post-scanning
Post-scanning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Michael H Buonocore, M.D., Ph.D., UC Davis Dept. of Radiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1999

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 3, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200210591

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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