Diagnosis, PsychiatricNCT00593931
Development Of New Techniques For Functional Magnetic Resonance Imaging Of The Brain
A study testing fMRI in people with Diagnosis, Psychiatric, run by University of California, Davis.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnosis, Psychiatric
- What is being tested?
- fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- May 1999to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- ability to give informed, written consent
- Not pregnant or breastfeeding
Who cannot join
- 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
About this study
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).
Read the 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.
- Conditions
- Diagnosis, Psychiatric
- Being tested
- fMRI
- Keywords
- Brain functional MRI
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
Functional Magnetic Resonance Imaging without contrast
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Normal Subjects Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
transient changes in blood flow in the brain that occurs with neuronal activity
Measured: Post-scanning
Secondary outcomes (1)
Sensitivity to blood oxygenation versus blood flow versus blood volume contrast mechanisms
Measured: Post-scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startMay 1999
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Principal Investigator is deceased
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis, PsychiatricStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael H Buonocore, M.D., Ph.D., Principal investigator, UC Davis Dept. of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593931
- Sponsor's protocol ID
- 200210591
- Status last verified
- May 2017
- First submitted
- 3 Jan 2008
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development Of New Techniques For Functional Magnetic Resonance Imaging Of The Brain
- ClinicalTrials.gov ID
- NCT00593931
- Acronym / sponsor ID
- 200210591
- Conditions
- Diagnosis, Psychiatric
- Keywords
- Brain functional MRI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator is deceased
- Enrolment
- 215 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- May 1999
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: fMRINormal Subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- ability to give informed, written consent
- Not pregnant or breastfeeding
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIFunctional Magnetic Resonance Imaging without contrast | Other | A |
Primary outcome
transient changes in blood flow in the brain that occurs with neuronal activity
Time frame: Post-scanning
1 secondary outcome
Sensitivity to blood oxygenation versus blood flow versus blood volume contrast mechanisms
Time frame: Post-scanning
Results and safety
The study was stopped early (reason given: Principal Investigator is deceased). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Buonocore, M.D., Ph.D. principal investigator
UC Davis Dept. of Radiology
Questions about this trial
What is this clinical trial studying?
A study testing fMRI in people with Diagnosis, Psychiatric, run by University of California, Davis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator is deceased). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transient changes in blood flow in the brain that occurs with neuronal activity (time frame: Post-scanning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.