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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pia C Maly Sundgren, MD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00723671
First received: July 25, 2008
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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 Intervention
Systemic Lupus Erythematosus
Fibromyalgia
Acute Neuropsychiatric Lupus
Procedure: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • differences in NAA [ Time Frame: years ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: November 2006
Study Completion Date: December 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: metabolic peaks Procedure: MRI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 25, 2008
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Encephalitis
Meningitis
Fibromyalgia
Myofascial Pain Syndromes
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
Central Nervous System Infections
Vascular Diseases
Cardiovascular Diseases
Vasculitis

ClinicalTrials.gov processed this record on October 19, 2014