Status:
COMPLETED
Magnetic Resonance Spectroscopy, Perfusion and Diffusion Tensor Imaging in Neuropsychiatric Lupus
Lead Sponsor:
University of Michigan
Conditions:
Systemic Lupus Erythematosus
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
NA
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 syste...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00723671
Start Date
November 1 2006
End Date
December 1 2013
Last Update
December 14 2015
Active Locations (1)
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1
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109