Status:
COMPLETED
Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus
Lead Sponsor:
University of Michigan
Conditions:
Neuropsychiatric Systemic Lupus Erythematosus
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if three functional Magnetic Resonance brain imaging techniques: Magnetic Resonance Spectroscopy(MRS),Magnetic Resonance perfusion, and Diffusion Tensor Imagi...
Detailed Description
Purpose of the Study: We plan with this study to obtain pilot data to support a larger grant application which will evaluate whether any of three types of functional Magnetic Resonance Imaging (known...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Have no diagnosis of NPSLE, SLE, or any other condition which, in the investigator's opinion, might cause central nervous system(CNS) changes or interfere with the interpretation of results.
- Be 18 years of age or older.
- Be willing and able to complete all study procedures.
- Meet the criteria for diagnosis of systemic lupus erythematosus(SLE).
- Have recent onset or diagnosis of neurological symptoms that have been active within the last 14 days. The criteria for NPSLE study patients will be neurological symptoms, confirmed by neurologic examination, which, in the opinion of the treating physician, may be due to the patient's diagnosis of SLE, and requires MRI evaluation. Patients will be classified according to the nomenclature recommended by the American College Rheumatology(ACR) on Neuropsychiatric Manifestations in SLE, and further classified as "focal," "nonfocal," or "seizure" (64).
- Be able to complete all study procedures; and be able to sign the informed consent form or have a designated proxy or next-of-kin present to provide consent on behalf of the subject.
- Meet the American College of Rheumatology(ACR) criteria for SLE and be a member of the U of M lupus cohort.
- Report no neurological symptoms at the time of enrollment.
- Exclusion criteria:
- 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, chronic obstructive pulmonary disease(COPD), chronic asthma), fibromyalgia(FM), 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.
- Subjects who are pregnant.
- Subjects who are left-handed.
- Those SLE patients with acute onset of neurological symptoms with duration longer than 14 days.
- Have acute onset of neurological symptoms related to systemic lupus erythematosus(SLE).
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00730002
Start Date
March 1 2008
End Date
December 1 2014
Last Update
December 14 2015
Active Locations (1)
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1
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109