Clinical trial NCT00730002: Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus
Official title: Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropsychiatric Systemic Lupus Erythematosus
Keywords: Lupus
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

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.

Eligibility criteria: 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), 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).

Primary outcomes:
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.
timeFrame: At 6 month intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
Study officials:
affiliation: University of Michigan
name: Pia Maly Sundgren, MD-PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Pia Maly Sundgren, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: