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

NCT04141046 | Terminated Results DMC FDA Device

• 1 other identifier: 19-0763
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; Depression

Keywords

Systemic lupus erythematosus; Lupus; SLE; Depression; Pain; Brain fog; Mood

Outcome Measures

Primary Outcomes (1)

• Change in Alpha Oscillation Power as Measured by RSEEG Recordings.

  Change in alpha oscillation power (8-12 Hz) will be measured between resting state electroencephalogram (RSEEG) recordings.

  Day 1, Day 5

Secondary Outcomes (9)

• Change in Correlation Between the IDAS Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).

  Day 1, Day 5

• Change in Correlation Between the PANAS Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).

  Day 1, Day 5

• Change in Correlation Between the Comparative Pain Scale Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).

  Day 1, Day 5

• Change in Correlation Between the Short Form Health Survey (SF-36) Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).

  Screening, 4 week

• Change in Correlation Between the FSMC Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).

  Day 1, Day 5

Other Outcomes (2)

• Change in Correlation Between Frontal Midline Alpha and Theta Activity (as Measured From EEG Recordings) and Accuracy at Cognitive Tasks Tasks.

  Day 1, Day 5

• Change in the WHODAS 2.0 Score.

  Day 1, 3 month

Study Arms (3)

Sham Stimulation

SHAM COMPARATOR

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

Device: XCSITE100 Stimulator - Active Sham

Theta-tACS

ACTIVE COMPARATOR

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.

Device: XCSITE100 Stimulator - Individualized theta-tACS

Alpha-tACS

EXPERIMENTAL

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.

Device: XCSITE100 Stimulator - Individualized alpha-tACS

Interventions

XCSITE100 Stimulator - Individualized theta-tACS DEVICE

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

Theta-tACS

XCSITE100 Stimulator - Individualized alpha-tACS DEVICE

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

Alpha-tACS

XCSITE100 Stimulator - Active Sham 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

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Depression; Pain; Mental Fatigue

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatigue

Results Point of Contact

• Title: Saira Sheikh, MD
• Organization: University of North Carolina at Chapel Hill

szsheikh@email.unc.edu

919-966-0545

Study Officials

• Saira Z Sheikh, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research team and the participants will not know the intervention assignment until data is un-blinded for analysis. The Principal Investigators (PI) and Co-Investigators (Co-I) will be blinded since they may be outcome assessors and/or sub-specialty care providers for some of the participants.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 28, 2019
• Study Start: January 1, 2019
• Primary Completion: July 12, 2023
• Study Completion: September 15, 2023
• Last Updated: June 27, 2024
• Results First Posted: June 27, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data sharing requests will become available starting from 9 to 36 months following publication.
• Access Criteria: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the interested investigator provides a (1) written request to the PI, (2) approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and (3) executes a data use/sharing agreement with UNC.

Locations

US (1)