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Sponsors and Collaborators: |
University of Michigan University of Michigan Health System |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00730002 |
The purpose of this study is to determine if three functional MR brain imaging techniques: MRS, MR perfusion, and DTI can detect brain alterations distinctive for NPSLE and SLE
Condition | Intervention |
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Neuropsychiatric Systemic Lupus Erythematosus |
Procedure: MRA Procedure: Magnetic resonance imaging Procedure: diffusion Imaging Procedure: perfusion imaging. |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus |
Estimated Enrollment: | 70 |
Study Start Date: | June 2006 |
Arms | Assigned Interventions |
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1: Active Comparator
Healthy Subjects
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Procedure: MRA
As part of the MR scan, you will need to lie still on a padded MR table inside the MR machine for about 15 minutes at a time while MR studies are being performed on you. The total time for the clinical portion of the MR study is approximately 35-40 minutes and there will be an additional 30 minutes for the research related MR studies. The total time you will spend on the MR table for this research will seldom be more than one hour.
Procedure: Magnetic resonance imaging
MR spectroscopy
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2: Active Comparator
SLE patients without neuropsychiatric symptoms.
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Procedure: Magnetic resonance imaging
MR spectroscopy
Procedure: MRA
MRA of the brain
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3.: Active Comparator
20 symptomatic NPSLE patients.
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Procedure: MRA
Procedure: diffusion Imaging
MRA of the Brain
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4: Active Comparator
10 Healthy Controls (HC) from an existing cohort as part of another sponsored study.
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Procedure: perfusion imaging.
MRA of the brain
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Purpose of the Study:
We plan with this study to obtain pilot data to support a larger grant application which will evaluate whether any of three types of functional Magnetic Resonance Imaging (known as MR Spectroscopy [MRS], MR Perfusion Imaging, and MR Diffusion Tensor Imaging [DTI]) can detect alterations in brain function distinctive for Neuropsychiatric Systemic Lupus Erythematosus (NPSLE), Systemic Lupus Erythematosus (SLE), and compare our findings to those found in an existing cohort of 20 normal healthy controls. Because this study is being done on a 3T scanner (3T Achieva, Philips Medical Systems) and our previous group of healthy controls was assessed using a 1.5 T scanner (LX EchoSpeed, GE Medical Systems), we propose to re-consent 10 of the previous 20 healthy controls and re-collect imaging data on the 3T scanner in order to confirm that our previously-collected data from the group of 20 healthy controls is still valid. This will confirm that the change of field strength and manufacturer does not affect data validity
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
Contact: Pia Maly Sundgren, MD, PHD | (734) 763-3253 | sundgren@umich.edu. |
United States, Michigan | |
University of Michigan Health Systems | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Pia Maly Sundgren, MD, PHD 734-763-3253 sundgren@umich.edu | |
Principal Investigator: Pia Maly Sundgren, MD,PHD |
Principal Investigator: | Pia Maly Sundgren, MD-PHD | University of Michigan |
Principal Investigator: | Pia Maly Sundgren, MD, PHD | University of Michigan |
Responsible Party: | University Of Michigan Health Systems ( Maly-Sundgren, Pia M.D., Ph.D. ) |
Study ID Numbers: | HUM00000714 |
Study First Received: | August 1, 2008 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00730002 |
Health Authority: | United States: Institutional Review Board |
Lupus |
Vasculitis Autoimmune Diseases Vascular Diseases Central Nervous System Diseases Lupus Vasculitis, Central Nervous System Brain Diseases Cerebrovascular Disorders |
Encephalitis Meningitis Lupus Erythematosus, Systemic Central Nervous System Infections Connective Tissue Diseases Autoimmune Diseases of the Nervous System |
Immune System Diseases Meningoencephalitis Nervous System Diseases Cardiovascular Diseases Vasculitis, Central Nervous System |