Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT00730002
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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00730002
Study Brief:
Protocol Section:
NCT00730002