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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pia C Maly Sundgren, MD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00730002
First received: August 1, 2008
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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 Intervention
Neuropsychiatric Systemic Lupus Erythematosus
Procedure: Magnetic Resonance Angiography (MRA)
Procedure: Magnetic resonance imaging
Procedure: MRA
Procedure: diffusion Imaging
Procedure: perfusion imaging.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: March 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Healthy Subjects
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
Systemic Lupus Erythematosus(SLE) patients without neuropsychiatric symptoms.
Procedure: Magnetic resonance imaging
MR spectroscopy
Other Name: MRA
Procedure: MRA
MRA of the brain
Active Comparator: 3.
20 symptomatic neuropsychiatric systemic lupus erythematosus(NPSLE) patients.
Procedure: MRA Procedure: diffusion Imaging
MRA of the Brain
Active Comparator: 4
10 Healthy Controls (HC) from an existing cohort as part of another sponsored study.
Procedure: perfusion imaging.
MRA of the brain

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730002

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

No publications provided

Responsible Party: Pia C Maly Sundgren, MD, PhD, Primary Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00730002     History of Changes
Other Study ID Numbers: HUM00000714
Study First Received: August 1, 2008
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Lupus

Additional relevant MeSH terms:
Encephalitis
Meningitis
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
Meningoencephalitis
Central Nervous System Infections
Vascular Diseases
Cardiovascular Diseases
Vasculitis

ClinicalTrials.gov processed this record on September 16, 2014