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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
Sponsor:
Information provided by (Responsible Party):
Pia C Maly Sundgren, MD, PhD, University of Michigan

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Fibromyalgia Acute Neuropsychiatric Lupus Procedure: MRI Not Applicable

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: metabolic peaks Procedure: MRI


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. differences in NAA [ Time Frame: years ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Pia Maly-Sundgren University of Michigan
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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