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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Systemic Lupus Erythematosus Acute Neuropsychiatric Lupus Autoimmune Diseases Connective Tissue Diseases Fibromyalgia Immune System Diseases Lupus Erythematosus, Systemic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI

Procedure

Primary outcomes

differences in NAA

Time frame: years

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2013
Study completion: 2013
First posted: Jul 29, 2008
Registry last updated: Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting