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

Primary Purpose

Systemic Lupus Erythematosus, Fibromyalgia, Acute Neuropsychiatric Lupus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Michigan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

metabolic peaks

Arm Description

Outcomes

Primary Outcome Measures

differences in NAA

Secondary Outcome Measures

Full Information

First Posted
July 25, 2008
Last Updated
December 10, 2015
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00723671
Brief Title
Magnetic Resonance Spectroscopy, Perfusion and Diffusion Tensor Imaging in Neuropsychiatric Lupus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Fibromyalgia, Acute Neuropsychiatric Lupus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metabolic peaks
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
differences in NAA
Time Frame
years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Maly-Sundgren
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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

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