Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus
NCT ID: NCT00730002
Last Updated: 2015-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2008-03-31
2014-12-31
Brief Summary
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Detailed Description
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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(tesla)scanner (3T(tesla) Achieva(Model name), Philips Medical Systems) and our previous group of healthy controls was assessed using a 1.5 T(tesla) scanner (LX EchoSpeed, General Electric(GE) Medical Systems), we propose to re-consent 10 of the previous 20 healthy controls and re-collect imaging data on the 3T(tesla) 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.
Recruiting Update as of March/2009: Enrollment is completed for Study Arms 1 and 2.
This study is only being conducted in Ann Arbor, Michigan. Travel reimbursement does not include hotel accommodations or air fare to and from Ann arbor, Michigan.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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1- Healthy Subjects
Healthy Subjects- receive MRA
Magnetic Resonance Angiography (MRA)
As part of the Magnetic Resonance(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.
Magnetic resonance imaging
MR spectroscopy
2 - patients with SLE, no neuropsych
Systemic Lupus Erythematosus(SLE) patients without neuropsychiatric symptoms - receive MRA
Magnetic resonance imaging
MR spectroscopy
MRA
MRA of the brain
3 - patients with SLE with neuropsych
20 symptomatic neuropsychiatric systemic lupus erythematosus(NPSLE) patients.
MRA
diffusion Imaging
MRA of the Brain
4- healthy patients from other cohort
10 Healthy Controls (HC) from an existing cohort as part of another sponsored study.
perfusion imaging.
MRA of the brain
Interventions
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Magnetic Resonance Angiography (MRA)
As part of the Magnetic Resonance(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.
Magnetic resonance imaging
MR spectroscopy
MRA
MRA of the brain
MRA
diffusion Imaging
MRA of the Brain
perfusion imaging.
MRA of the brain
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be 18 years of age or older.
* Be willing and able to complete all study procedures.
* Meet the criteria for diagnosis of systemic lupus erythematosus(SLE).
* Have recent onset or diagnosis of neurological symptoms that have been active within the last 14 days. The criteria for NPSLE study patients will be neurological symptoms, confirmed by neurologic examination, which, in the opinion of the treating physician, may be due to the patient's diagnosis of SLE, and requires MRI evaluation. Patients will be classified according to the nomenclature recommended by the American College Rheumatology(ACR) on Neuropsychiatric Manifestations in SLE, and further classified as "focal," "nonfocal," or "seizure" (64).
* Be able to complete all study procedures; and be able to sign the informed consent form or have a designated proxy or next-of-kin present to provide consent on behalf of the subject.
* Meet the American College of Rheumatology(ACR) criteria for SLE and be a member of the U of M lupus cohort.
* Report no neurological symptoms at the time of enrollment.
Exclusion Criteria
* Any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), current suicide risk or attempt within 2 years of the study, or substance abuse within 2 years.
* Subjects who are pregnant.
* Subjects who are left-handed.
* Those SLE patients with acute onset of neurological symptoms with duration longer than 14 days.
* Have acute onset of neurological symptoms related to systemic lupus erythematosus(SLE).
18 Years
99 Years
ALL
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Pia C Maly Sundgren, MD, PhD
Primary Investigator
Principal Investigators
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Pia Maly Sundgren, MD-PHD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Pia Maly Sundgren, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Health Systems
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00000714
Identifier Type: -
Identifier Source: org_study_id