Last updated: April 25, 2024
Sponsor: Northwell Health
Overall Status: Active - Recruiting
Phase
N/A
Condition
Systemic Lupus Erythematosus
Lupus
Cutaneous Lupus Erythematosus
Treatment
Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest.
Clinical Study ID
NCT06378736
21-1027
Ages 18-65 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Must be able to understand and provide informed consent.
- Must be ≥18 and ≤65years of age.
- Must be female.
- Must fulfill the 1997 American College of Rheumatology (ACR) revised criteria for thediagnosis of SLE or the Systemic Lupus Erythematosus International CollaboratingClinics (SLICC) Criteria for SLE.
- Must have stable disease activity and medication doses for 4 weeks prior to screening.Stable disease activity is defined as no increase in disease activity requiring anincrease or change in medications.
- Must be on a corticosteroid dose that is ≤ prednisone 10 mg daily, or equivalent.
- Aim 1 ONLY: Must have demonstrated significantly increased metabolism in thehippocampus, temporal or parietal lobes on prior fluoro-deoxy glucose (FDG)-PETimaging.
Exclusion
Exclusion Criteria:
- Inability or unwillingness to give written informed consent or comply with studyprotocol.
- History of neurological diseases including, but not limited to, severe head injury orhistory of brain surgery, stroke, seizure, toxic exposure, mental retardation,migraine headaches, multiple sclerosis, dementia.
- History of documented transient ischemic attacks within 6 months of screening.
- History of illicit drug or alcohol dependence/abuse within the past 12 months.
- Current use of antipsychotic, anticonvulsant, antidepressant (except for selectiveserotonin reuptake inhibitors) or anxiolytic medications (short acting anxiolyticmedications are allowed if taken as needed with > 5 half-lives prior to assessments).
- History of chronic pain; current and/or chronic use of narcotic analgesia for > 21days (total) within the last 3 months, or last dose less than 5 days prior toassessment.
- Increased disease activity within 4 weeks of screening defined by an increase inSLEDAI by 3 points or more, exclusive of points from serologies, which prompts anincrease in or new addition of SLE medications.
- History of a diagnosis of a primary psychiatric disorder preceding SLE diagnosis.
- Current active acute infections requiring antibiotics within 2 weeks of screening andchronic known infections (eg. hepatitis B, C, and/or HIV).
- Co-existing other autoimmune disease(s) other than autoimmune thyroid disease andsecondary Sjogren's Syndrome.
- The presence of uncontrolled, severe hypertension, diabetes or heart disease.
- Impaired renal function with an estimated glomerular filtration rate (eGFR)< 30.
- Presence of any active medical condition that in the opinion of the investigator maycontribute to cognitive and/or behavioral disturbances.
- Use of investigational drugs within 30 days or 5 half-lives before the study visit,whichever is longer.
- Past or current medical problems or findings from physical examination or laboratorytesting that are not listed above, which, in the opinion of the investigator, may poseadditional risks from participation in the study, may interfere with the participant'sability to comply with study requirements or that may impact the quality orinterpretation of the data obtained from the study.
- Current treatment with cyclophosphamide, addition of belimumab within 4 months,addition of any disease modifying drug or biologic within 3 months of screening,and/or rituxan within 6 months.
- Limited fluency with English or Spanish that in the opinion of the investigator wouldlimit the subject's performance on the assessments.
- Pregnant and/or lactating women.
Study Design
Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest.
Phase:
Study Start date:
January 22, 2024
Estimated Completion Date:
March 23, 2026
Study Description
Connect with a study center
Northwell Health-Feinstein Insitute
Manhasset, New York 11030
United StatesActive - Recruiting
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