Clinical trial NCT00593931: 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
Overall status: TERMINATED
Phase: NA
Conditions: Diagnosis, Psychiatric
Keywords: Brain functional MRI
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: transient changes in blood flow in the brain that occurs with neuronal activity
timeFrame: Post-scanning
Secondary outcomes:
measure: Sensitivity to blood oxygenation versus blood flow versus blood volume contrast mechanisms
timeFrame: Post-scanning
Other outcomes:
Locations:
Study officials:
affiliation: UC Davis Dept. of Radiology
name: Michael H Buonocore, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: