Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus - Full Text View

Sponsors and Collaborators:	University of Michigan University of Michigan Health System
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00730002

Purpose

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
Neuropsychiatric Systemic Lupus Erythematosus	Procedure: MRA Procedure: Magnetic resonance imaging Procedure: diffusion Imaging Procedure: perfusion imaging.

MedlinePlus related topics: MRI Scans

U.S. FDA Resources

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

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:	June 2006

Arms	Assigned Interventions
1: Active Comparator Healthy Subjects	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
2: Active Comparator SLE patients without neuropsychiatric symptoms.	Procedure: Magnetic resonance imaging MR spectroscopy Procedure: MRA MRA of the brain
3.: Active Comparator 20 symptomatic NPSLE patients.	Procedure: MRA Procedure: diffusion Imaging MRA of the Brain
4: Active Comparator 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 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

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 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 ACR criteria for diagnosis of 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 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 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, COPD, chronic asthma), 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 SLE.

Contacts and Locations

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

Contacts

Contact: Pia Maly Sundgren, MD, PHD

(734) 763-3253

sundgren@umich.edu.

Locations

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

Sponsors and Collaborators

University of Michigan

University of Michigan Health System

Investigators

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

More Information

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

Keywords provided by University of Michigan:

Lupus

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Immune System Diseases
Meningoencephalitis
Nervous System Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System

ClinicalTrials.gov processed this record on January 16, 2009