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

Primary Purpose

Systemic Lupus Erythematosus, Depression

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

XCSITE100 Stimulator - Individualized theta-tACS

XCSITE100 Stimulator - Individualized alpha-tACS

XCSITE100 Stimulator - Active Sham

About this trial

This is an interventional basic science trial for Systemic Lupus Erythematosus focused on measuring Systemic lupus erythematosus, Lupus, SLE, Depression, Pain, Brain fog, Mood

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of North Carolina at Chapel HillRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Experimental

Arm Label

Sham Stimulation

Theta-tACS

Alpha-tACS

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in correlation between the IDAS score and alpha oscillation power (as measured by resting state EEG recordings).

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).

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).

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).

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).

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).

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).

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).

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).

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.

Full Information

NCT ID

NCT04141046

First Posted

October 24, 2019

Last Updated

June 28, 2023

Sponsor

University of North Carolina, Chapel Hill

1. Study Identification

Unique Protocol Identification Number

NCT04141046

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product

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.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus, Depression

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sham Stimulation

Arm Type

Sham Comparator

Arm Description

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

Arm Title

Theta-tACS

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Alpha-tACS

Arm Type

Experimental

Arm Description

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 Type

Device

Intervention Name(s)

XCSITE100 Stimulator - Individualized theta-tACS

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

XCSITE100 Stimulator - Individualized alpha-tACS

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

XCSITE100 Stimulator - Active Sham

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in alpha oscillation power as measured by RSEEG recordings.

Description

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

Time Frame

Day 1, Day 5

Secondary Outcome Measure Information:

Title

Change in correlation between the IDAS score and alpha oscillation power (as measured by resting state EEG recordings).

Description

Time Frame

Day 1, Day 5

Title

Change in correlation between the PANAS score and alpha oscillation power (as measured by resting state EEG recordings).

Description

Time Frame

Day 1, Day 5

Title

Change in correlation between the Comparative Pain Scale score and alpha oscillation power (as measured by resting state EEG recordings).

Description

Time Frame

Day 1, Day 5

Title

Change in correlation between the Short Form Health Survey (SF-36) score and alpha oscillation power (as measured by resting state EEG recordings).

Description

Time Frame

Screening, 4 week

Title

Change in correlation between the FSMC score and alpha oscillation power (as measured by resting state EEG recordings).

Description

Time Frame

Day 1, Day 5

Title

Change in correlation between the PCS score and alpha oscillation power (as measured by resting state EEG recordings).

Description

Time Frame

Day 1, Day 5

Title

Change in correlation between the YMRS score and alpha oscillation power (as measured by resting state EEG recordings).

Description

Time Frame

Day 1, Day 5

Title

Change in correlation between the HDRS17 score and alpha oscillation power (as measured by resting state EEG recordings).

Description

Time Frame

Day 1, Day 5

Title

Change in correlation between the HAM-A score and alpha oscillation power (as measured by resting state EEG recordings).

Description

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.

Time Frame

Day 1, Day 5

Other Pre-specified Outcome Measures:

Title

Change in correlation between frontal midline alpha and theta activity (as measured from EEG recordings) and accuracy at cognitive tasks tasks.

Description

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.

Time Frame

Day 1, Day 5

Title

Change in the WHODAS 2.0 score.

Description

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.

Time Frame

Day 1, 3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shruti Saxena Beem

Phone

+1 (919) 966-0545

shruti_saxena@med.unc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Roger Huamani

Phone

+1 (919) 966-5688

roger_huamani@med.unc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saira Z Sheikh, MD

Organizational Affiliation

UNC Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emily McCormick

Phone

919-843-8890

First Name & Middle Initial & Last Name & Degree

Saira Z Sheikh, MD

First Name & Middle Initial & Last Name & Degree

Flavio Frolich, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD will be shared upon request.

IPD Sharing Time Frame

Data sharing requests will become available starting from 9 to 36 months following publication.

IPD Sharing 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.

Learn more about this trial

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

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