CompletedNot Applicable

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

United States66 participantsStarted 2008-03

Plain-language 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).

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion criteria: * 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), cardiopulmonar…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

This pilot data will be used to strengthen our application for a larger grant to definitively study the sensitivity and specificity of these alterations.

Timeframe: At 6 month intervals

Trial details

NCT IDNCT00730002

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

View on ClinicalTrials.gov More Neuropsychiatric Systemic Lupus Erythematosus trials