LUPUS Brain: tACS to Target the Neurophysiology of Depression, Cognitive Deficits, and Pain in Patients With SLE
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.
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 complete 2 blood draws and cheek swabs to assess for the presence of Bartonella spp. bacteria.
Participants will also be asked to complete self-report surveys via REDCap at a 3-month time point measured from completion of the intervention.
Study Design
Conditions
Systemic Lupus Erythematosus
Intervention
XCSITE100 Stimulator - Individualized theta-tACS, XCSITE100 Stimulator - Individualized alpha-tACS, XCSITE100 Stimulator - Active Sham
Location
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
United States
27599
Status
Not yet recruiting
Source
University of North Carolina, Chapel Hill
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04141046
- ClinicalTrials.gov processed this data on October 31, 2019
Published on BioPortfolio: 2019-10-31T14:29:40-0400
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Medical and Biotech [MESH] Definitions
Inducible T-cell Co-stimulator Ligand
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