NCT04141046

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

LUPUS Brain: Transcranial Alternating Current Stimulation (tACS) to Target the Neurophysiology of Depression, Cognitive Deficits, and Pain in Patients With Systemic Lupus Erythematosus (SLE)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Systemic Lupus Erythematosus
• Depression

Interventions

Type	Name	Description
DEVICE	XCSITE100 Stimulator - Individualized theta-tACS	20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
DEVICE	XCSITE100 Stimulator - Individualized alpha-tACS	20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
DEVICE	XCSITE100 Stimulator - Active Sham	20 seconds of ramp-in to 40 seconds of 10 Hz tACS with a ramp out of 20 seconds for a total of 80 seconds of stimulation

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-07-12
• Completion: 2023-09-15
• First posted: 2019-10-28
• Last updated: 2024-06-27
• Results posted: 2024-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study