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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | July 1997 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001591 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Functional and Metabolic Imaging Using Magnetic Resonance Imaging and Spectroscopy |
| Official Title ICMJE | Functional and Metabolic Imaging Using Magnetic Resonance Imaging and Spectroscopy |
| Brief Summary | Technical advances in magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) have provided researchers with the opportunity to study changes of the central nervous system (CNS) and improve diagnosis and therapy of CNS disease. New MRI and MRS techniques specifically designed for functional MRI (fMRI) and MRS imaging of the CNS will be evaluated in normal volunteers and in patients with CNS diseases. This study will develop and evaluate new magnetic resonance pulse sequences for performing MRI or MRS and compare the results to existing MR techniques. Patients and volunteers age 18 and older are eligible for the study. A history will be taken in which exclusion criteria (such as having a pacemaker or cochlear implants) will be addressed, and a pregnancy test will be administered to women of childbearing age. Each subject will also be asked to fill out a questionnaire. Study participants will lie in the MRI scanner from 20 minutes to 2 hours. A coil may be placed on the head and participants may be asked to do simple or complex tasks. A catheter will be placed in an arm vein and a contrast agent will be administered. This agent will allow structures in the brain to show up more clearly. |
| Detailed Description | Technical advances in Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) have provided researchers with the opportunity to study functional and metabolic changes of the central nervous system (CNS) in both normal individuals and individuals with neurological diseases in response to sensory, motor or cognitive stimulation. New MRI and MRS techniques specifically designed for Functional Magnetic Resonance Imaging (fMRI) and Magnetic Resonance Spectroscopic Imaging of the CNS will be evaluated at 1.5 and/or at 4.0 Tesla on normal volunteers and in patients with CNS pathology. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 450 |
| Completion Date | July 2003 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | INCLUSION CRITERIA: Any normal volunteer age 18 and over who is capable of giving informed consent. For the purposes of evaluating new techniques for fMRI, patients will be considered the same as volunteers. EXCLUSION CRITERIA: A subject will be excluded if he/she has a contraindication to MR scanning such as the following: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular foreign body or implant (e.g., metal shavings, retinal clips); breast implants or Insulin pump. Subjects who have a history of a reaction to MR contrast agents specifically gadopentetate dimeglumine will be excluded from participating in the contrast agent administration part of this protocol. The contraindications to MRI at 1.5 Tesla and 4 Tesla are identical. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001591 |
| Responsible Party | |
| Study ID Numbers ICMJE | 970152, 97-CC-0152 |
| Study Sponsor ICMJE | National Institutes of Health Clinical Center (CC) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | July 2003 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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