MedTrace Logo

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

NCT04141046 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-06-27

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Saira Z Sheikh, MD · UNC Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-07-12
Completion
2023-09-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141046 on ClinicalTrials.gov