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

Fibromyalgia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723671
• Other study ID #: HUM00050562
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: December 10, 2015
• Start date: November 2006
• Est. completion date: December 2013

Study information

• Verified date: December 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Neuropsychiatric Lupus
• Fibromyalgia
• Lupus Erythematosus, Systemic
• Lupus Vasculitis, Central Nervous System
• Systemic Lupus Erythematosus

Intervention

Procedure:
• MRI

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences in NAA		years	No