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

December 10, 2015 updated by: Pia C Maly Sundgren, MD, PhD, University of Michigan
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Magnetic resonance imaging
Procedure: Magnetic resonance imaging
MR spectroscopy
Other Names:
  • 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 Names:
  • MRA
Procedure: MRA
MRA of the brain
Procedure: MRA
ACTIVE_COMPARATOR: 3 - patients with SLE with neuropsych
20 symptomatic neuropsychiatric systemic lupus erythematosus(NPSLE) patients.
Procedure: MRA
MRA of the brain
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At 6 month intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Pia Maly Sundgren, MD-PHD, University of Michigan
  • Principal Investigator: Pia Maly Sundgren, MD, PHD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

August 1, 2008

First Submitted That Met QC Criteria

August 1, 2008

First Posted (ESTIMATE)

August 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00000714

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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