Systemic Lupus ErythematosusNCT00723671
Magnetic Resonance Spectroscopy, Perfusion and Diffusion Tensor Imaging in Neuropsychiatric Lupus
A study testing MRI in people with Systemic Lupus Erythematosus and Fibromyalgia, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus, Fibromyalgia, Acute Neuropsychiatric Lupus
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
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.
- Being tested
- MRI
- Medical subject headings
- Lupus Erythematosus, Systemic, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| metabolic peaks | Experimental | Not described Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in NAA
Measured: years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startNov 2006
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia C Maly Sundgren, MD, PhD, University of Michigan
- Investigators
- Pia Maly-Sundgren, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723671
- Sponsor's protocol ID
- HUM00050562
- Status last verified
- Dec 2015
- First submitted
- 25 Jul 2008
- Last updated
- 14 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Spectroscopy, Perfusion and Diffusion Tensor Imaging in Neuropsychiatric Lupus
- ClinicalTrials.gov ID
- NCT00723671
- Acronym / sponsor ID
- HUM00050562
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metabolic peaks | Experimental | Procedure: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI | Procedure or surgery | metabolic peaks |
Primary outcome
differences in NAA
Time frame: years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pia Maly-Sundgren principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Systemic Lupus Erythematosus and Fibromyalgia, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in NAA (time frame: years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.