Magnetic Resonance Spectroscopy, Perfusion and Diffusion Tensor Imaging in Neuropsychiatric Lupus
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ClinicalTrials.gov Identifier: NCT00723671 |
Recruitment Status
:
Completed
First Posted
: July 29, 2008
Last Update Posted
: December 14, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus Fibromyalgia Acute Neuropsychiatric Lupus | Procedure: MRI | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: metabolic peaks | Procedure: MRI |
- differences in NAA [ Time Frame: years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723671
United States, Michigan | |
University of Michigan Hospital | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Pia Maly-Sundgren | University of Michigan |
Responsible Party: | Pia C Maly Sundgren, MD, PhD, Principal Investigator, University of Michigan |
ClinicalTrials.gov Identifier: | NCT00723671 History of Changes |
Other Study ID Numbers: |
HUM00050562 |
First Posted: | July 29, 2008 Key Record Dates |
Last Update Posted: | December 14, 2015 |
Last Verified: | December 2015 |
Additional relevant MeSH terms:
Fibromyalgia Lupus Erythematosus, Systemic Lupus Vasculitis, Central Nervous System Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Vasculitis, Central Nervous System |
Autoimmune Diseases of the Nervous System Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Meningoencephalitis Encephalitis Central Nervous System Viral Diseases Central Nervous System Infections Meningitis Vascular Diseases Cardiovascular Diseases Vasculitis |