Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus
1 other identifier
interventional
66
1 country
1
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 Imaging(DTI) can detect brain alterations distinctive for neuropsychiatric systemic lupus erythematosus (NPSLE)and systemic lupus erythematosus(SLE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 1, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 14, 2015
December 1, 2015
6.5 years
August 1, 2008
December 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
This pilot data will be used to strengthen our application for a larger grant to definitively study the sensitivity and specificity of these alterations.
At 6 month intervals
Study Arms (4)
1- Healthy Subjects
ACTIVE COMPARATORHealthy Subjects- receive MRA
2 - patients with SLE, no neuropsych
ACTIVE COMPARATORSystemic Lupus Erythematosus(SLE) patients without neuropsychiatric symptoms - receive MRA
3 - patients with SLE with neuropsych
ACTIVE COMPARATOR20 symptomatic neuropsychiatric systemic lupus erythematosus(NPSLE) patients.
4- healthy patients from other cohort
ACTIVE COMPARATOR10 Healthy Controls (HC) from an existing cohort as part of another sponsored study.
Interventions
As part of the Magnetic Resonance(MR) scan, you will need to lie still on a padded MR table inside the MR machine for about 15 minutes at a time while MR studies are being performed on you. The total time for the clinical portion of the MR study is approximately 35-40 minutes and there will be an additional 30 minutes for the research related MR studies. The total time you will spend on the MR table for this research will seldom be more than one hour.
MR spectroscopy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Health Systems
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pia Maly Sundgren, MD-PHD
University of Michigan
- PRINCIPAL INVESTIGATOR
Pia Maly Sundgren, MD, PHD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
August 1, 2008
First Posted
August 8, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
December 14, 2015
Record last verified: 2015-12