LUPUS Brain: tACS to Target the Neurophysiology of Depression, Cognitive Deficits, and Pain in Patients With SLE

Last updated: May 30, 2024
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Terminated

Phase

N/A

Condition

Memory Loss

Lupus

Bone Diseases

Treatment

XCSITE100 Stimulator - Individualized theta-tACS

XCSITE100 Stimulator - Active Sham

XCSITE100 Stimulator - Individualized alpha-tACS

Clinical Study ID

NCT04141046
19-0763
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to investigate the effects of a type of non-invasive transcranial alternating current stimulation (tACS) on patients diagnosed with systemic lupus erythematosus (SLE) who are experiencing depression.

Targeting depression in patients with SLE may provide benefit to these patients, as there is a clear relationship between chronic pain and depression. The investigators propose that a tACS stimulation montage that was previously used in depression could be beneficial to patients with SLE, resulting in reduced depression symptoms, thus resulting in reduced chronic pain and cognitive difficulties.

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

Total Participants: 4
Treatment Group(s): 3
Primary Treatment: XCSITE100 Stimulator - Individualized theta-tACS
Phase:
Study Start date:
January 01, 2019
Estimated Completion Date:
September 15, 2023

Study Description

At the initial session, consent will be obtained and eligibility will be determined.

Eligible participants will undergo a structural MRI as part of the screening process, then be randomized and have 5 consecutive daily, 40 minute stimulation sessions.

Participants will be randomly assigned to one of three groups: sham stimulation, individualized alpha-tACS (usually 8-12 Hz), or individualized theta-tACS (individualized alpha frequency minus 4 Hz). Participation will include 1 to 11 visits.

Neurophysiological measures will be taken before and after the stimulation sessions on the first and fifth days of the intervention, as well as the 2-week follow-up and 4-week follow-up visits. Psychiatric clinical assessments will be performed at baseline (Day 1 of stimulation), Day 5 of stimulation, and at both follow-up visits using the Hamilton Depression Rating Scale (HDRS17), the Hamilton Anxiety Rating Scale (HAM-A), the Inventory of Depression and Anxiety Symptoms (IDAS), and the Comparative Pain Scale Chart. All participants will also be asked to complete self-report surveys via REDCap at a 3-month time point measured from completion of the intervention.

Connect with a study center

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

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