search
Back to results

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

Primary Purpose

Diagnosis, Psychiatric

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fMRI
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diagnosis, Psychiatric focused on measuring Brain functional MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    A

    Arm Description

    Normal Subjects

    Outcomes

    Primary Outcome Measures

    transient changes in blood flow in the brain that occurs with neuronal activity

    Secondary Outcome Measures

    Sensitivity to blood oxygenation versus blood flow versus blood volume contrast mechanisms

    Full Information

    First Posted
    January 3, 2008
    Last Updated
    May 25, 2017
    Sponsor
    University of California, Davis
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00593931
    Brief Title
    Development Of New Techniques For Functional Magnetic Resonance Imaging Of The Brain
    Official Title
    Development Of New Techniques For Functional Magnetic Resonance Imaging Of The Brain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Principal Investigator is deceased
    Study Start Date
    May 1999 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Davis

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diagnosis, Psychiatric
    Keywords
    Brain functional MRI

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    215 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Normal Subjects
    Intervention Type
    Other
    Intervention Name(s)
    fMRI
    Intervention Description
    Functional Magnetic Resonance Imaging without contrast
    Primary Outcome Measure Information:
    Title
    transient changes in blood flow in the brain that occurs with neuronal activity
    Time Frame
    Post-scanning
    Secondary Outcome Measure Information:
    Title
    Sensitivity to blood oxygenation versus blood flow versus blood volume contrast mechanisms
    Time Frame
    Post-scanning

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael H Buonocore, M.D., Ph.D.
    Organizational Affiliation
    UC Davis Dept. of Radiology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs