Phase
Condition
Memory Loss
Lupus
Bone Diseases
Treatment
XCSITE100 Stimulator - Individualized theta-tACS
XCSITE100 Stimulator - Active Sham
XCSITE100 Stimulator - Individualized alpha-tACS
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ages 18-65 years
Meets SLE diagnosis criteria
Low suicide risk
Not experiencing a manic episode
Stable on all SLE and psychiatric medications for 6 weeks prior to screening
Capacity to understand all relevant risks and potential benefits of the study
Exclusion
Exclusion Criteria:
Drug-induced SLE and any other rheumatologic or autoimmune disease diagnosis (exceptfor Sjogren's syndrome and mixed connective tissue disease)
Medical illness (unstable cardiac disease, AIDS, liver or renal impairment, ormalignant disease within 5 years before screening visit) or treatment of same thatcould interfere with study participation
Neurological disorders, including but not limited to history of seizures (exceptchildhood febrile seizures and electroconvulsive therapy induced seizures),dementia, history of stroke, Parkinson's disease, multiple sclerosis, cerebralaneurysm; History of moderate to severe traumatic brain injury (TBI); Frequent orsevere migraines in the past 30 days before the screening visit
History of positive hepatitis B, hepatitis C antibody, HIV antibody/antigen;Opportunistic infection in the 12 weeks before initial study dosing OR currentlyundergoing treatment for a chronic opportunistic infection (TB, pneumocystispneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypicalmycobacteria); Acute OR chronic infection requiring hospitalization in the 30 daysbefore screening visit AND/OR administration of parenteral (IV or IM) antibacterial,antiviral, antifungal, or anti-parasitic agents in the 30 days before screeningvisit
Have received intravenous glucocorticoids at a dosage of ≥ 500mg daily within thepast month; Current use of benzodiazepines or anti-epileptic drugs
History of thrombophlebitis or thromboembolic disorders (e.g., blood clots) orserious adverse reactions to blood draws
Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of alcoholof substance abuse (other than nicotine) within the last month or a DSM-IV diagnosisof alcohol or substance dependence (other than nicotine) within the last 6 months;Prior or current diagnosis of bipolar disorder, manic episodes, hypomanic episodes,or mixed episodes; Prior or current diagnosis of a psychotic disorder
Prior brain surgery; Any brain devices/implants, including cochlear implants andaneurysm clips or other factors that are contraindicated for undergoing an MRI
Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birthcontrol measures during study participation
Concurrent medical condition or treatment for a medical disorder that, in theopinion of the investigator, could confound interpretation of results or affect thepatient's ability to fully participate in the study.
Anything that, in the opinion of the investigator, would place the participant atincreased risk or preclude the participant's full compliance with or completion ofthe study
Non-English speakers
Study Design
Study Description
Connect with a study center
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
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