Study Stopped
Changes to funding
Tests of Functional Magnetic Resonance Imaging Techniques
Imaging Techniques in fMRI and fMRI Reproducibility: An NIH/FDA Interagency Collaboration
2 other identifiers
observational
13
1 country
1
Brief Summary
Background: \- Functional magnetic resonance imaging (fMRI) is used to study the brain. It takes a series of pictures that can be used to look at how the brain processes information. It is used to study problems with thinking, language, and movement, among other things. Researchers are working to develop new and better fMRI techniques. To test these techniques, they want to perform fMRI scans on healthy volunteers. Objectives: \- To test different fMRI techniques in healthy volunteers. Eligibility: \- Healthy volunteers at least 18 years of age. Design:
- Participants will be screened with a physical exam and medical history.
- Participants will have fMRI scans of the brain. During these scans, they will be asked to perform simple tasks. These tasks may involve language, thinking, or motor skills. The scanning sessions will last up to 2 hours.
- Participants may be asked to return for additional fMRI scans over several years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2012
CompletedFirst Posted
Study publicly available on registry
October 23, 2012
CompletedStudy Start
First participant enrolled
March 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedNovember 22, 2021
November 1, 2021
2.6 years
October 20, 2012
November 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
evaluation of fMRI techniques
To test different fMRI techniques in healthy volunteers.
Study day 1, followup visit(s)
Study Arms (1)
Volunteers
Healthy Volunteers
Eligibility Criteria
Healthy volunteers willing to come to NIH or are already part of an existing NIH protocol.
You may qualify if:
- Healthy volunteers, new or from current NIH protocols are eligible. Healthy volunteers will be defined according the history obtained from reported medical history, medical record (reported at registration), the MRI safety questionnaire, and a clinical grade noncontrast brain MRI.
- Willing to travel to the NIH for follow-up visits
- Greater than 18 years old
- Able to understand and sign informed consent.
- Bilingual or multilingual subjects can participate in this study as long as the subjects are also fluent in English. Subjects do not need to be native or monolingual speakers of English.
You may not qualify if:
- The following criteria will be used to exclude subjects from participating in this protocol:
- Implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damages from twisting in a Magnetic field. Examples:
- Aneurysm clip, implanted neural stimulator,
- Implanted cardiac pacemaker, defibrillator, or certain other implanted electrical or metallic devices,
- Cochlear implant, ocular foreign body (metal shavings),
- Any implanted device (pumps, infusion devices, etc.),
- Shrapnel injuries,
- History of metal in head or eyes or other parts of the body.
- Vagus Nerve Stimulators (VNS)
- Subjects with tattoos that contain metal.
- Pregnant women
- Over 350 lbs because of the weight limit of the MRI table
- Prior surgery that may render performing the MRI to be unsafe.
- Untreatable claustrophobia otherwise requiring anesthesia or antianxiety medications that may alter the subject s ability to perform the tasks during fMRI scanning.
- Subjects will be asked to refrain from drinking or eating caffeinated foods or drinks the morning of the scan that can result in vessel vasoconstriction prior to the scan.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Hennig J, Speck O, Koch MA, Weiller C. Functional magnetic resonance imaging: a review of methodological aspects and clinical applications. J Magn Reson Imaging. 2003 Jul;18(1):1-15. doi: 10.1002/jmri.10330.
PMID: 12815634BACKGROUNDBennett CM, Miller MB. How reliable are the results from functional magnetic resonance imaging? Ann N Y Acad Sci. 2010 Mar;1191:133-55. doi: 10.1111/j.1749-6632.2010.05446.x.
PMID: 20392279BACKGROUNDPillai JJ. The evolution of clinical functional imaging during the past 2 decades and its current impact on neurosurgical planning. AJNR Am J Neuroradiol. 2010 Feb;31(2):219-25. doi: 10.3174/ajnr.A1845.
PMID: 20150316BACKGROUND
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Nadia M Biassou, M.D.
National Institutes of Health Clinical Center (CC)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2012
First Posted
October 23, 2012
Study Start
March 19, 2015
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
November 22, 2021
Record last verified: 2021-11