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

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ClinicalTrials.gov Identifier: NCT04141046
Recruitment Status : Suspended (Suspended due to COVID-19 risks)
First Posted : October 28, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE October 24, 2019
First Posted Date  ICMJE October 28, 2019
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2019)
Change in alpha oscillation power as measured by RSEEG recordings. [ Time Frame: Day 1, Day 5 ]
Change in alpha oscillation power (8-12 Hz) will be measured between resting state electroencephalogram (RSEEG) recordings.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2019)
  • Change in correlation between the IDAS score and alpha oscillation power (as measured by resting state EEG recordings). [ Time Frame: Day 1, Day 5 ]
    The Inventory of Depression and Anxiety Symptoms (IDAS) Scale is a 10 symptom scale (General depression, Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions) used to assess depression and anxiety related disorders. The scale ranges from 1 to 5 with 1 equal to "not at all" and 5 equal to"extremely". Higher scores indicate a greater experience of a given symptom.
  • Change in correlation between the PANAS score and alpha oscillation power (as measured by resting state EEG recordings). [ Time Frame: Day 1, Day 5 ]
    The Positive and Negative Affect Schedule (PANAS) will be used to measure positive and negative emotion. This 20-item self-reported survey will measure 10 positive and 10 negative affective states. Positive affect score ranges from 10-50 and higher scores indicate a greater positive affect. Negative affect scores range from 10-50 with higher scores indicating a greater negative affect.
  • Change in correlation between the Comparative Pain Scale score and alpha oscillation power (as measured by resting state EEG recordings). [ Time Frame: Day 1, Day 5 ]
    The Comparative Pain Scale score will assess for self-reported pain. The scale ranges from 0 to 10, with 0 equal to "pain free" and 10 equal to "unmanageable, unspeakable". Higher scores reflect a higher severity of self-reported pain.
  • Change in correlation between the Short Form Health Survey (SF-36) score and alpha oscillation power (as measured by resting state EEG recordings). [ Time Frame: Screening, 4 week ]
    The 36-Item Short Form Health Survey (SF-36) measures general health using 36 questions. There are 8 individual health "domains" or categories that each receive their own score, and from these 8 individual scores an overall score can be obtained. Overall scores can range from 0-100, with higher scores indicating better overall health.
  • Change in correlation between the FSMC score and alpha oscillation power (as measured by resting state EEG recordings). [ Time Frame: Day 1, Day 5 ]
    The Fatigue Scale for Motor and Cognitive Functions (FSMC) will measure self-reported levels of physical and mental fatigue. This 20-item survey will measure 10 motor fatigue items and 10 cognitive fatigue items. The scale ranges from 1 to 5 with 1 equal to "does not apply at all" and 5 equal to "applies completely". Total scores can range from 20 to 100 with higher scores indicating worse fatigue.
  • Change in correlation between the PCS score and alpha oscillation power (as measured by resting state EEG recordings). [ Time Frame: Day 1, Day 5 ]
    The Pain Catastrophizing Scale (PCS) will assess for self-reported pain. The survey consists of 13 items with a 5-point scale, where 0 equals"not at all" and 4 equals "all the time". Total scores can range from 0 to 52 with higher scores indicating a greater frequency in which individuals experience pain-related thoughts and feelings.
  • Change in correlation between the YMRS score and alpha oscillation power (as measured by resting state EEG recordings). [ Time Frame: Day 1, Day 5 ]
    The Young Mania Rating Scale (YMRS) will assess for manic symptoms at baseline and over the period of the study. The 11 item scale ranges from 0 to 56 with higher scores indicating more severe manic symptoms.
  • Change in correlation between the HDRS17 score and alpha oscillation power (as measured by resting state EEG recordings). [ Time Frame: Day 1, Day 5 ]
    The Hamilton Depression Rating Scale (HDRS17) will assess for the severity of depressive symptoms in the patients. The scale ranges from 0 to 52 with higher scores indicating a greater severity of depressive symptoms.
  • Change in correlation between the HAM-A score and alpha oscillation power (as measured by resting state EEG recordings). [ Time Frame: Day 1, Day 5 ]
    The Hamilton Anxiety (HAM-A) scale will assess for the severity of anxiety symptoms. The scale ranges from 0 to 30 with higher scores indicating greater anxiety.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 24, 2019)
  • Change in correlation between frontal midline alpha and theta activity (as measured from EEG recordings) and accuracy at cognitive tasks tasks. [ Time Frame: Day 1, Day 5 ]
    Participants will complete various tasks paired with electroencephalogram (EEG) recordings to assess physiological changes. Participants will be asked to perform sustained attention, selective attention, and working memory tasks with EEG recordings.
  • Change in the WHODAS 2.0 score. [ Time Frame: Day 1, 3 month ]
    The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) will assess for co morbid disabilities. This 12-item survey ranges from 0 to 4 with 0 being "none" and 4 being "extreme or cannot do". Total scores can range from 0 to 48 with higher scores lower levels of social functioning.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE LUPUS Brain: tACS to Target the Neurophysiology of Depression, Cognitive Deficits, and Pain in Patients With SLE
Official Title  ICMJE LUPUS Brain: Transcranial Alternating Current Stimulation (tACS) to Target the Neurophysiology of Depression, Cognitive Deficits, and Pain in Patients With Systemic Lupus Erythematosus (SLE)
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 complete 2 blood draws and cheek swabs to assess for the presence of Bartonella spp. bacteria.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Basic Science
Condition  ICMJE
  • Systemic Lupus Erythematosus
  • Depression
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Sham Comparator: 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.
    Intervention: Device: XCSITE100 Stimulator - Active Sham
  • Active Comparator: 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.
    Intervention: Device: XCSITE100 Stimulator - Individualized theta-tACS
  • Experimental: 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.
    Intervention: Device: XCSITE100 Stimulator - Individualized alpha-tACS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: October 24, 2019)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages 18-65 years
  • Meets SLE diagnosis criteria
  • Low suicide risk
  • Not experiencing a manic episode
  • Stable on all 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04141046
Other Study ID Numbers  ICMJE 19-0763
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD will be shared upon request.
Supporting Materials: Study Protocol
Supporting Materials: 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.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Saira Z Sheikh, MD UNC Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP