Study of New Magnetic Resonance Imaging Methods of the Brain
|First Received Date ICMJE||February 18, 2000|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||February 17, 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00004577 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study of New Magnetic Resonance Imaging Methods of the Brain|
|Official Title ICMJE||Characterization of Brain Morphology and Activity Using Functional and Anatomical MRI Contrast|
The purpose of this investigation is to develop improved magnetic resonance imaging (MRI) techniques and hardware for studying brain function. MRI is a diagnostic tool that provides information about brain chemistry and physiology. This study will evaluate new MRI methods for monitoring blood flow to regions of the brain in response to simple tasks. The MRI machine used in this study is more powerful than those in most hospitals, permitting a higher visual resolution.
Normal healthy volunteers over 18 years old may be eligible for this study. Candidates will be screened with a medical history and questionnaire, and a neurological examination. Study participants will have a yearly MRI scan. For this procedure, the subject lies on a stretcher that is moved into a donut-shaped machine with a strong magnetic field. A lightweight circular or rectangular coil a device that improves the quality of the images may be placed on the head. The scan time varies from 20 minutes to 3 hours; most scans last between 45 and 90 minutes. During the scan, the subject may perform simple tasks, such as listening to tapes, tapping a finger, moving a hand, watching a screen, or smelling a fragrance. More complex tasks may require thinking about tones or pictures and responding to them by pressing buttons.
Information from this study will be used to develop better imaging methods that will, in turn, permit a greater understanding of normal and abnormal brain behaviors.
The goal of this protocol is to improve the spatial resolution and sensitivity in MRI studies of the changes in hemodynamics that occur in the central nervous system (CNS) in healthy controls in response to sensory, motor, or cognitive stimulation.
CNS functional changes will be characterized by measuring blood flow, blood transit time, and blood oxygenation. These studies are required in order to develop and implement new imaging techniques for research and clinical applications on the 3.0T and 7.0T MRI. A secondary goal is to evaluate the feasibility to combine brain recording techniques, electro-encephalography (EEG) and Magnetoencephalography (MEG), with MRI.
Techniques will be developed for anatomical and spectroscopic MRI that can take advantage of 7T field strength, extending parallel imaging strategies to 7T to realize the full gain in sensitivity. The aim is to obtain very high resolution anatomical MRI, high temporal and spatial resolution blood oxygenation (BOLD) and blood flow (perfusion) images, and spectroscopic studies of metabolites of the brain. All of these techniques will be performed on normal, healthy volunteers.
Any healthy, male or female volunteer between 18-65 years of age; the subjects must be capable of understanding the procedures and requirements of this study and be willing to sign an informed consent document.
The is a technical development study design to develop and evaluate new MR pulse sequences and hardware for performing MRI and functional MRI in the CNS at 3.0T and 7T with a high spatial resolution.
The primary outcome of this study will be the ability to acquire anatomical and functional images of the human brain with high spatial resolution, i.e. 100-300 micron and 750-1000 micron respectively. The relative merits of blood flow and BOLD fMRI techniques, and their particular signal characteristics will be established. In addition, we anticipate the ability to acquire (proton) spectroscopic data at 5mm resolution. Another outcome will be the ability to acquire artifact-free EEG data concurrently with the functional MRI data.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||650|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
All Subjects will answer the NMR safety screening form (Appendix C) and the
Healthy volunteer form (Appendix B). A subject will be excluded if he/she:
airway disease, heart failure, coronary artery disease, and history of sleep apnea.
The contraindications to MRI at both 3.0 T and 7T are almost identical, except the 7T also excludes ferromagnetic dental bridges and/or crowns.
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00004577|
|Other Study ID Numbers ICMJE||000082, 00-N-0082|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Neurological Disorders and Stroke (NINDS)|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||October 5, 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP