Systemic Lupus ErythematosusNCT04141046
LUPUS Brain: tACS to Target the Neurophysiology of Depression, Cognitive Deficits, and Pain in Patients With SLE
A study testing XCSITE100 Stimulator - Individualized theta-tACS and XCSITE100 Stimulator - Individualized alpha-tACS in people with Systemic Lupus Erythematosus and Depression, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Depression
- What is being tested?
- XCSITE100 Stimulator - Individualized theta-tACS and XCSITE100 Stimulator - Individualized alpha-tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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)
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.
Read the 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
- Being tested
- XCSITE100 Stimulator - Individualized theta-tACS, XCSITE100 Stimulator - Individualized alpha-tACS, XCSITE100 Stimulator - Active Sham
- Keywords
- Systemic lupus erythematosus, Lupus, SLE, Depression, Pain, Brain fog, Mood
- Medical subject headings
- Lupus Erythematosus, Systemic, Depression, Pain, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XCSITE100 Stimulator - Individualized theta-tACSDevice
20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
XCSITE100 Stimulator - Individualized alpha-tACSDevice
20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
XCSITE100 Stimulator - Active ShamDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: XCSITE100 Stimulator - Individualized alpha-tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: Day 1, Day 5
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.
Measured: Day 1, Day 5
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.
Measured: 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).
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.
Measured: Screening, 4 week
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.
Measured: Day 1, Day 5
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.
Measured: Day 1, Day 5
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.
Measured: Day 1, Day 5
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.
Measured: Day 1, Day 5
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.
Measured: Day 1, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Jan 2019
- Primary completion12 Jul 2023
- Study completion15 Sep 2023
Why it stopped: Terminated due to end of funding period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saira Z Sheikh, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141046
- Sponsor's protocol ID
- 19-0763
- Status last verified
- May 2024
- First submitted
- 24 Oct 2019
- Last updated
- 27 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04141046
- Acronym / sponsor ID
- 19-0763
- Conditions
- Systemic Lupus Erythematosus, Depression
- Keywords
- Systemic lupus erythematosus, Lupus, SLE, Depression, Pain, Brain fog, Mood
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to end of funding period.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Posted 27 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation | Sham comparator | Device: XCSITE100 Stimulator - Active ShamThis is a sham/placebo arm that receives some stimulation, mimicking the skin sensations associated with tACS to enhance success of patient blinding. |
| Theta-tACS | Active comparator | Device: XCSITE100 Stimulator - Individualized theta-tACSThis 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. |
| Alpha-tACS | Experimental | Device: XCSITE100 Stimulator - Individualized alpha-tACSThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XCSITE100 Stimulator - Individualized theta-tACS20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation | Device | Theta-tACS |
| XCSITE100 Stimulator - Individualized alpha-tACS20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation | Device | Alpha-tACS |
| XCSITE100 Stimulator - Active Sham20 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 | Device | Sham Stimulation |
Primary outcome
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.
9 secondary outcomes
Change in Correlation Between the IDAS Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
Time frame: Day 1, Day 5
Change in Correlation Between the PANAS Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
Time frame: Day 1, Day 5
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
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
Change in Correlation Between the FSMC Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
Time frame: Day 1, Day 5
Change in Correlation Between the PCS Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
Time frame: Day 1, Day 5
Change in Correlation Between the YMRS Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
Time frame: Day 1, Day 5
Change in Correlation Between the HDRS17 Score and Alpha Oscillation Power (as Measured by Resting State EEG Recordings).
Time frame: Day 1, Day 5
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saira Z Sheikh, MD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XCSITE100 Stimulator - Individualized theta-tACS and XCSITE100 Stimulator - Individualized alpha-tACS in people with Systemic Lupus Erythematosus and Depression, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alpha Oscillation Power as Measured by RSEEG Recordings. (time frame: Day 1, Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.