Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00730002
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : December 14, 2015
Information provided by (Responsible Party):
Pia C Maly Sundgren, MD, PhD, University of Michigan

Brief Summary:
The purpose of this study is to determine if three functional Magnetic Resonance brain imaging techniques: Magnetic Resonance Spectroscopy(MRS),Magnetic Resonance perfusion, and Diffusion Tensor Imaging(DTI) can detect brain alterations distinctive for neuropsychiatric systemic lupus erythematosus (NPSLE)and systemic lupus erythematosus(SLE).

Condition or disease Intervention/treatment Phase
Neuropsychiatric Systemic Lupus Erythematosus Procedure: Magnetic Resonance Angiography (MRA) Procedure: Magnetic resonance imaging Procedure: MRA Procedure: diffusion Imaging Procedure: perfusion imaging. Not Applicable

Detailed Description:

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(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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus
Study Start Date : March 2008
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1- Healthy Subjects
Healthy Subjects- receive MRA
Procedure: 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.
Other Name: Magnetic resonance imaging
Procedure: Magnetic resonance imaging
MR spectroscopy
Other Name: MRA
Active Comparator: 2 - patients with SLE, no neuropsych
Systemic Lupus Erythematosus(SLE) patients without neuropsychiatric symptoms - receive MRA
Procedure: Magnetic resonance imaging
MR spectroscopy
Other Name: MRA
Procedure: MRA
MRA of the brain
Active Comparator: 3 - patients with SLE with neuropsych
20 symptomatic neuropsychiatric systemic lupus erythematosus(NPSLE) patients.
Procedure: MRA Procedure: diffusion Imaging
MRA of the Brain
Active Comparator: 4- healthy patients from other cohort
10 Healthy Controls (HC) from an existing cohort as part of another sponsored study.
Procedure: perfusion imaging.
MRA of the brain

Primary Outcome Measures :
  1. This pilot data will be used to strengthen our application for a larger grant to definitively study the sensitivity and specificity of these alterations. [ Time Frame: At 6 month intervals ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Have no diagnosis of NPSLE, SLE, or any other condition which, in the investigator's opinion, might cause central nervous system(CNS) changes or interfere with the interpretation of results.
  • 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:

  • Co-morbid medical illnesses capable of causing a worsening of physical functional status independent of the diagnosis (e.g. morbid obesity, autoimmune diseases other than SLE), cardiopulmonary disorders (e.g. angina, congestive heart failure, chronic obstructive pulmonary disease(COPD), chronic asthma), fibromyalgia(FM), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, Type I diabetes), and malignancy within 2 years, excluding successfully treated squamous or basal skin carcinoma.
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00730002

United States, Michigan
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Principal Investigator: Pia Maly Sundgren, MD-PHD University of Michigan
Principal Investigator: Pia Maly Sundgren, MD, PHD University of Michigan

Responsible Party: Pia C Maly Sundgren, MD, PhD, Primary Investigator, University of Michigan Identifier: NCT00730002     History of Changes
Other Study ID Numbers: HUM00000714
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Pia C Maly Sundgren, MD, PhD, University of Michigan:

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Vasculitis, Central Nervous System
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Central Nervous System Viral Diseases
Central Nervous System Infections
Vascular Diseases
Cardiovascular Diseases