Study of New Magnetic Resonance Imaging Methods of the Brain
|First Received Date ICMJE||February 18, 2000|
|Last Updated Date||December 5, 2013|
|Start Date ICMJE||February 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 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 1.5T, 3.0T, and the 7.0T.
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 perfusion images, and spectroscopic studies of metabolites of the brain. All of these developments will be performed on normal, healthy volunteers.
|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 Group/Cohort (s)||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||500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Any neurologically and psychiatrically normal, male or female, healthy volunteer over 18 years old. Subjects must be capable of understanding the procedures and requirements of this study. Subjects must be willing to sign an informed consent document.
A subject will be excluded if he/she has a contraindication to MR scanning such as the following: pregnancy, aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body (e.g. metal shavings), insulin pump or any pre-existing eye conditions. Subjects who underwent brain surgery, who have a central nervous system illness, neurological lesion, a psychiatric history or recurrent migraines that require medication will also be excluded from this study. Uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease. The contraindications to MRI at both 1.5 T and 3.0 T are identical. The 7T additionally excludes any ferromagnetic dental bridges or crowns. Additionally, Transcranial Direct-Current Stimulation (tDCS) subjects we be exclude them from this protocol for any broken skin or lesions in the area of the electrodes; the presence of metal in the cranial cavity and/or holes in the skull made by trauma or surgery.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00004577|
|Other Study ID Numbers ICMJE||000082, 00-N-0082|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|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||November 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP