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

Primary Purpose

Neuropsychiatric Systemic Lupus Erythematosus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magnetic Resonance Angiography (MRA)

Magnetic resonance imaging

MRA

diffusion Imaging

perfusion imaging.

About this trial

This is an interventional diagnostic trial for Neuropsychiatric Systemic Lupus Erythematosus focused on measuring Lupus

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

University of Michigan Health Systems

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

1- Healthy Subjects

2 - patients with SLE, no neuropsych

3 - patients with SLE with neuropsych

4- healthy patients from other cohort

Arm Description

Healthy Subjects- receive MRA

Systemic Lupus Erythematosus(SLE) patients without neuropsychiatric symptoms - receive MRA

20 symptomatic neuropsychiatric systemic lupus erythematosus(NPSLE) patients.

10 Healthy Controls (HC) from an existing cohort as part of another sponsored study.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00730002

First Posted

August 1, 2008

Last Updated

December 10, 2015

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT00730002

Brief Title

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

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropsychiatric Systemic Lupus Erythematosus

Keywords

Lupus

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1- Healthy Subjects

Arm Type

Active Comparator

Arm Description

Healthy Subjects- receive MRA

Arm Title

2 - patients with SLE, no neuropsych

Arm Type

Active Comparator

Arm Description

Systemic Lupus Erythematosus(SLE) patients without neuropsychiatric symptoms - receive MRA

Arm Title

3 - patients with SLE with neuropsych

Arm Type

Active Comparator

Arm Description

20 symptomatic neuropsychiatric systemic lupus erythematosus(NPSLE) patients.

Arm Title

4- healthy patients from other cohort

Arm Type

Active Comparator

Arm Description

10 Healthy Controls (HC) from an existing cohort as part of another sponsored study.

Intervention Type

Procedure

Intervention Name(s)

Magnetic Resonance Angiography (MRA)

Other Intervention Name(s)

Magnetic resonance imaging

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Magnetic resonance imaging

Other Intervention Name(s)

MRA

Intervention Description

MR spectroscopy

Intervention Type

Procedure

Intervention Name(s)

MRA

Intervention Description

MRA of the brain

Intervention Type

Procedure

Intervention Name(s)

MRA

Intervention Type

Procedure

Intervention Name(s)

diffusion Imaging

Intervention Description

MRA of the Brain

Intervention Type

Procedure

Intervention Name(s)

perfusion imaging.

Intervention Description

MRA of the brain

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pia Maly Sundgren, MD-PHD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pia Maly Sundgren, MD, PHD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan Health Systems

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

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

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