Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus
Status: | Completed |
---|---|
Conditions: | Lupus |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 4/21/2016 |
Start Date: | March 2008 |
End Date: | December 2014 |
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).
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).
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.
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.
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).
We found this trial at
1
site
Click here to add this to my saved trials