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

Sponsored by:	University of Michigan
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00723671

Purpose

The purpose of this study is to find out if certain types of Magnetic Resonance (MR) scanning will help to better detect markers in the brain that are related to the neuropsychiatric symptoms of systemic lupus erythematosus (SLE). A small percentage of patients who have this type of lupus experience symptoms that may result from a blood clot or change in blood vessel structure in the brain. These neuropsychiatric symptoms can include an inability to think clearly, a change in level of awake and/or awareness, and in the worst cases, seizure and stroke. Another goal of the study is to find out if individuals with fibromyalgia (FM), or chronic pain, have symptom-related markers in any of these scans as well. Better and earlier detection of markers that are related to acute neuropsychiatric lupus (NPSLE) and FM will be helpful to all who are affected by these diseases.

Condition	Intervention
Systemic Lupus Erythematosus Fibromyalgia Acute Neuropsychiatric Lupus	Other: MRI

MedlinePlus related topics: Fibromyalgia Lupus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized

Further study details as provided by University of Michigan:

Estimated Enrollment:	100
Study Start Date:	November 2006
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:Inclusion Criteria:

Meet the American College of Rheumatology (ACR) criteria for SLE with neuropsychiatric symptoms.
Be 18 years of age or older.
Have recent onset of neurological symptoms that have been active within the last 14 days. The criteria for NPSLE study patients will be a clinically significant neurologic examination which, in the opinion of the treating physician, may be due to 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" [68].
Be willing and able to complete all study procedures and sign the informed consent form.
Report no neurological symptoms at the time of enrollment.
The patients meeting the baseline criteria will be sequentially enrolled from the Lupus Cohort. Recruitment will be adjusted to include equal numbers of APA positive and APA negative patients.
Meet the established ACR criteria for FM [69].
Be willing and able to complete all study procedures associated with baseline scanning.

Exclusion Criteria:

Those SLE patients with acute onset of neurological symptoms with duration longer than 14 days.
Individuals who are pregnant.
Individuals who are left-handed.
Individuals who meet 1990 ACR criteria for FM
Have acute onset of neurological symptoms related to SLE.
Individuals who are pregnant.
Individuals who are left-handed.
Individuals who meet ACR criteria for FM.
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), 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.
Individuals with mood disorders will not be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723671

Contacts

Contact: Pia M Sundgren, MD, PhD

734.763.3253

sundgren@med.umich.edu

Locations

United States, Michigan
University of Michigan Hospital	Recruiting
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

More Information

Responsible Party:	UNiversity of Michigan Department of Radiology ( Pia Maly Sundgren )
Study ID Numbers:	2003-0199
Study First Received:	July 25, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00723671
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Vasculitis
Autoimmune Diseases
Fibromyalgia
Myofascial Pain Syndromes
Vascular Diseases
Central Nervous System Diseases
Pain
Lupus Vasculitis, Central Nervous System
Rheumatic Diseases
Brain Diseases

Cerebrovascular Disorders
Encephalitis
Meningitis
Muscular Diseases
Central Nervous System Infections
Lupus Erythematosus, Systemic
Musculoskeletal Diseases
Neuromuscular Diseases
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