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

NCT ID: NCT04141046

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-09-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Sham Stimulation

This is a sham/placebo arm that receives some stimulation, mimicking the skin sensations associated with tACS to enhance success of patient blinding.

Group Type: SHAM_COMPARATOR

XCSITE100 Stimulator - Active Sham

Intervention Type: DEVICE

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

Theta-tACS

This arm targets theta oscillations in the somatosensory cortex to see if there is a decrease in the experience of depression, pain, or brain fog in lupus patients.

Group Type: ACTIVE_COMPARATOR

XCSITE100 Stimulator - Individualized theta-tACS

Intervention Type: DEVICE

20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation

Alpha-tACS

This arm targets alpha oscillations in the somatosensory cortex to see if there is a decrease in the experience of depression, pain, or brain fog in lupus patients.

Group Type: EXPERIMENTAL

XCSITE100 Stimulator - Individualized alpha-tACS

Intervention Type: DEVICE

20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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 Criteria

• Drug-induced SLE and any other rheumatologic or autoimmune disease diagnosis (except for Sjogren's syndrome and mixed connective tissue disease)
• Medical illness (unstable cardiac disease, AIDS, liver or renal impairment, or malignant disease within 5 years before screening visit) or treatment of same that could interfere with study participation
• Neurological disorders, including but not limited to history of seizures (except childhood febrile seizures and electroconvulsive therapy induced seizures), dementia, history of stroke, Parkinson's disease, multiple sclerosis, cerebral aneurysm; History of moderate to severe traumatic brain injury (TBI); Frequent or severe 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 currently undergoing treatment for a chronic opportunistic infection (TB, pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria); Acute OR chronic infection requiring hospitalization in the 30 days before screening visit AND/OR administration of parenteral (IV or IM) antibacterial, antiviral, antifungal, or anti-parasitic agents in the 30 days before screening visit
• Have received intravenous glucocorticoids at a dosage of ≥ 500mg daily within the past month; Current use of benzodiazepines or anti-epileptic drugs
• History of thrombophlebitis or thromboembolic disorders (e.g., blood clots) or serious adverse reactions to blood draws
• Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of alcohol of substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of 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 and aneurysm clips or other factors that are contraindicated for undergoing an MRI
• Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation
• Concurrent medical condition or treatment for a medical disorder that, in the opinion of the investigator, could confound interpretation of results or affect the patient's ability to fully participate in the study.
• Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
• Non-English speakers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saira Z Sheikh, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-0763

Identifier Type: -

Identifier Source: org_study_id