LUPUS Brain: tACS to Target the Neurophysiology of Depression, Cognitive

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04141046
Study type	Interventional
Source	University of North Carolina, Chapel Hill
Contact	Shruti Saxena Beem
Phone	+1 (919) 966-0545
Email	shruti_saxena@med.unc.edu
Status	Recruiting
Phase	N/A
Start date	January 1, 2019
Completion date	January 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms