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



Status:Completed
Conditions:Fibromyalgia, Lupus
Therapuetic Areas:Immunology / Infectious Diseases, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2006
End Date:December 2013

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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.


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.
We found this trial at
1
site
Ann Arbor, Michigan 48109
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from
Ann Arbor, MI
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