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
About this trial
This is an interventional diagnostic trial for Diagnosis, Psychiatric focused on measuring Brain functional MRI
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
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
NCT ID
NCT00593931
First Posted
January 3, 2008
Last Updated
May 25, 2017
Sponsor
University of California, Davis
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
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