CClinicalTrials.gg
Sign In
CompletedNCT00723671Updated Dec 14, 2015

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

An interventional study of MRI in Systemic Lupus Erythematosus, Fibromyalgia and Acute Neuropsychiatric Lupus, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-14.

Sponsored by University of Michigan · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Systemic Lupus Erythematosus
  • Fibromyalgia
  • Acute Neuropsychiatric Lupus
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 66 is close to the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    metabolic peaks

    Procedure: MRI

Interventions

  • ProcedureMRI
06

What researchers measure

Primary outcomes

  1. differences in NAA

    Time frame: years

07

Study locations

1 site
  • University of Michigan Hospital
    Ann Arbor, Michigan 48109, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00723671
Lead sponsor
University of Michigan
Responsible party
Pia C Maly Sundgren, MD, PhD (Principal Investigator, University of Michigan) — Principal investigator
First posted
Jul 29, 2008
Start date
Nov 2006
Primary completion
Apr 2013
Completion
Dec 2013
Last update
Dec 14, 2015

Study contacts

Pia Maly-Sundgren
principal investigator · University of Michigan
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lupus Vasculitis, Central Nervous System

Other studies from this sponsor

University of Michigan

Start the discussion