Neuropsychiatric Systemic Lupus ErythematosusNCT00730002
Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus
A study testing Magnetic Resonance Angiography (MRA), Magnetic resonance imaging and MRA in people with Neuropsychiatric Systemic Lupus Erythematosus, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropsychiatric Systemic Lupus Erythematosus
- What is being tested?
- Magnetic Resonance Angiography (MRA), Magnetic resonance imaging and MRA
- 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
- Mar 2008to Dec 2014
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
About this study
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).
Read the detailed description
Purpose of the Study:
We plan with this study to obtain pilot data to support a larger grant application which will evaluate whether any of three types of functional Magnetic Resonance Imaging (known as MR Spectroscopy [MRS], MR Perfusion Imaging, and MR Diffusion Tensor Imaging [DTI]) can detect alterations in brain function distinctive for Neuropsychiatric Systemic Lupus Erythematosus (NPSLE), Systemic Lupus Erythematosus (SLE), and compare our findings to those found in an existing cohort of 20 normal healthy controls. Because this study is being done on a 3T(tesla)scanner (3T(tesla) Achieva(Model name), Philips Medical Systems) and our previous group of healthy controls was assessed using a 1.5 T(tesla) scanner (LX EchoSpeed, General Electric(GE) Medical Systems), we propose to re-consent 10 of the previous 20 healthy controls and re-collect imaging data on the 3T(tesla) scanner in order to confirm that our previously-collected data from the group of 20 healthy controls is still valid. This will confirm that the change of field strength and manufacturer does not affect data validity.
Recruiting Update as of March/2009: Enrollment is completed for Study Arms 1 and 2.
This study is only being conducted in Ann Arbor, Michigan. Travel reimbursement does not include hotel accommodations or air fare to and from Ann arbor, Michigan.
- Being tested
- Magnetic Resonance Angiography (MRA), Magnetic resonance imaging, MRA, diffusion Imaging, perfusion imaging.
- Keywords
- Lupus
- Medical subject headings
- Lupus Vasculitis, Central Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Angiography (MRA)Procedure or surgery
Also called Magnetic resonance imaging
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.
Magnetic resonance imagingProcedure or surgery
Also called MRA
MR spectroscopy
MRAProcedure or surgery
MRA of the brain
MRAProcedure or surgery
diffusion ImagingProcedure or surgery
MRA of the Brain
perfusion imaging.Procedure or surgery
MRA of the brain
| Study group | Role | What they receive |
|---|---|---|
| 1- Healthy Subjects | Active comparator | Healthy Subjects- receive MRA Receives: Procedure: Magnetic Resonance Angiography (MRA); Procedure: Magnetic resonance imaging |
| 2 - patients with SLE, no neuropsych | Active comparator | Systemic Lupus Erythematosus(SLE) patients without neuropsychiatric symptoms - receive MRA Receives: Procedure: Magnetic resonance imaging; Procedure: MRA |
| 3 - patients with SLE with neuropsych | Active comparator | 20 symptomatic neuropsychiatric systemic lupus erythematosus(NPSLE) patients. Receives: Procedure: MRA; Procedure: diffusion Imaging |
| 4- healthy patients from other cohort | Active comparator | 10 Healthy Controls (HC) from an existing cohort as part of another sponsored study. Receives: Procedure: perfusion imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
This pilot data will be used to strengthen our application for a larger grant to definitively study the sensitivity and specificity of these alterations.
Measured: At 6 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropsychiatric 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
- Non-randomised
- Intervention model
- Parallel groups
- 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, MD-PHD, Principal investigator, University of MichiganPia Maly Sundgren, MD, PHD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730002
- Sponsor's protocol ID
- HUM00000714
- Status last verified
- Dec 2015
- First submitted
- 1 Aug 2008
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- 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
- NCT00730002
- Acronym / sponsor ID
- HUM00000714
- Keywords
- Lupus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Aug 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 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).
Detailed description
Purpose of the Study:
We plan with this study to obtain pilot data to support a larger grant application which will evaluate whether any of three types of functional Magnetic Resonance Imaging (known as MR Spectroscopy [MRS], MR Perfusion Imaging, and MR Diffusion Tensor Imaging [DTI]) can detect alterations in brain function distinctive for Neuropsychiatric Systemic Lupus Erythematosus (NPSLE), Systemic Lupus Erythematosus (SLE), and compare our findings to those found in an existing cohort of 20 normal healthy controls. Because this study is being done on a 3T(tesla)scanner (3T(tesla) Achieva(Model name), Philips Medical Systems) and our previous group of healthy controls was assessed using a 1.5 T(tesla) scanner (LX EchoSpeed, General Electric(GE) Medical Systems), we propose to re-consent 10 of the previous 20 healthy controls and re-collect imaging data on the 3T(tesla) scanner in order to confirm that our previously-collected data from the group of 20 healthy controls is still valid. This will confirm that the change of field strength and manufacturer does not affect data validity.
Recruiting Update as of March/2009: Enrollment is completed for Study Arms 1 and 2.
This study is only being conducted in Ann Arbor, Michigan. Travel reimbursement does not include hotel accommodations or air fare to and from Ann arbor, Michigan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1- Healthy Subjects | Active comparator | Procedure: Magnetic Resonance Angiography (MRA), Procedure: Magnetic resonance imagingHealthy Subjects- receive MRA |
| 2 - patients with SLE, no neuropsych | Active comparator | Procedure: Magnetic resonance imaging, Procedure: MRASystemic Lupus Erythematosus(SLE) patients without neuropsychiatric symptoms - receive MRA |
| 3 - patients with SLE with neuropsych | Active comparator | Procedure: MRA, Procedure: diffusion Imaging20 symptomatic neuropsychiatric systemic lupus erythematosus(NPSLE) patients. |
| 4- healthy patients from other cohort | Active comparator | Procedure: perfusion imaging.10 Healthy Controls (HC) from an existing cohort as part of another sponsored study. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Magnetic Resonance Angiography (MRA)Also: Magnetic resonance imagingAs 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. | Procedure or surgery | 1- Healthy Subjects |
| Magnetic resonance imagingAlso: MRAMR spectroscopy | Procedure or surgery | 1- Healthy Subjects, 2 - patients with SLE, no neuropsych |
| MRAMRA of the brain | Procedure or surgery | 2 - patients with SLE, no neuropsych |
| MRA | Procedure or surgery | 3 - patients with SLE with neuropsych |
| diffusion ImagingMRA of the Brain | Procedure or surgery | 3 - patients with SLE with neuropsych |
| perfusion imaging.MRA of the brain | Procedure or surgery | 4- healthy patients from other cohort |
Primary outcome
This pilot data will be used to strengthen our application for a larger grant to definitively study the sensitivity and specificity of these alterations.
Time frame: At 6 month intervals
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.
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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, MD-PHD principal investigator
University of Michigan
Pia Maly Sundgren, MD, PHD 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 Magnetic Resonance Angiography (MRA), Magnetic resonance imaging and MRA in people with Neuropsychiatric Systemic Lupus Erythematosus, 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 6 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?
This pilot data will be used to strengthen our application for a larger grant to definitively study the sensitivity and specificity of these alterations. (time frame: At 6 month intervals). 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.