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

NCT00723671 | Completed

• 1 other identifier: HUM00050562
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus; Fibromyalgia; Acute Neuropsychiatric Lupus

Outcome Measures

Primary Outcomes (1)

• differences in NAA

  years

Study Arms (1)

metabolic peaks

EXPERIMENTAL

Procedure: MRI

Interventions

MRI PROCEDURE

metabolic peaks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 obstructive pulmonary disease), 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Fibromyalgia

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Pia Maly-Sundgren

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: November 1, 2006
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

US (1)