Overview

This trial is active, not recruiting.

Condition diagnosis, psychiatric
Treatment fmri
Sponsor University of California, Davis
Start date May 1999
End date May 2015
Trial size 240 participants
Trial identifier NCT00593931, 200210591

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Normal Subjects
fmri
Functional Magnetic Resonance Imaging without contrast

Primary Outcomes

Measure
transient changes in blood flow in the brain that occurs with neuronal activity
time frame: Post-scanning

Secondary Outcomes

Measure
Sensitivity to blood oxygenation versus blood flow versus blood volume contrast mechanisms
time frame: Post-scanning

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Development Of New Techniques For Functional Magnetic Resonance Imaging Of The Brain
Principal investigator Michael H Buonocore, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by University of California, Davis.