Clinical trial NCT04141046: LUPUS Brain: tACS to Target the Neurophysiology of Depression, Cognitive Deficits, and Pain in Patients With SLE
Official title: LUPUS Brain: Transcranial Alternating Current Stimulation (tACS) to Target the Neurophysiology of Depression, Cognitive Deficits, and Pain in Patients With Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Depression
Keywords: Systemic lupus erythematosus
Lupus
SLE
Depression
Pain
Brain fog
Mood
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in Alpha Oscillation Power as Measured by RSEEG Recordings.
timeFrame: Day 1, Day 5
Secondary outcomes:
measure: Change in Correlation Between the IDAS Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
timeFrame: Day 1, Day 5
measure: Change in Correlation Between the PANAS Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
timeFrame: Day 1, Day 5
measure: Change in Correlation Between the Comparative Pain Scale Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
timeFrame: Day 1, Day 5
measure: Change in Correlation Between the Short Form Health Survey (SF-36) Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
timeFrame: Screening, 4 week
measure: Change in Correlation Between the FSMC Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
timeFrame: Day 1, Day 5
measure: Change in Correlation Between the PCS Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
timeFrame: Day 1, Day 5
measure: Change in Correlation Between the YMRS Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
timeFrame: Day 1, Day 5
measure: Change in Correlation Between the HDRS17 Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
timeFrame: Day 1, Day 5
measure: Change in Correlation Between the HAM-A Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
timeFrame: Day 1, Day 5
Other outcomes:
measure: Change in Correlation Between Frontal Midline Alpha and Theta Activity (as Measured From EEG Recordings) and Accuracy at Cognitive Tasks Tasks.
timeFrame: Day 1, Day 5
measure: Change in the WHODAS 2.0 Score.
timeFrame: Day 1, 3 month
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Saira Z Sheikh, MD
role: PRINCIPAL_INVESTIGATOR
References: