Systemic Lupus ErythematosusNCT06378736
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by Northwell Health at 1 site in United States.
Trial summary
Patients with systemic lupus erythematosus (SLE) often experience a frustrating decline of their cognitive skills that includes considerable problems in attention, learning, and memory. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest.
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 23 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Twenty of the SLE subjects that have participated in prior brain imaging studies. The other 20 SLE subjects will be recruited from 2 ongoing observational studies of brain involvement in SLE.
Who may be able to join
- Must be able to understand and provide informed consent.
- Must be ≥18 and ≤65years of age.
- Must be female.
- Must fulfill the 1997 American College of Rheumatology (ACR) revised criteria for the diagnosis of SLE or the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) Criteria for SLE.
- Must have stable disease activity and medication doses for 4 weeks prior to screening. Stable disease activity is defined as no increase in disease activity requiring an increase or change in medications.
- Must be on a corticosteroid dose that is ≤ prednisone 10 mg daily, or equivalent.
- Must have demonstrated significantly increased metabolism in the hippocampus, temporal or parietal lobes on prior fluoro-deoxy glucose (FDG)-PET imaging.
Who cannot join
- Inability or unwillingness to give written informed consent or comply with study protocol.
- History of neurological diseases including, but not limited to, severe head injury or history of brain surgery, stroke, seizure, toxic exposure, mental retardation, migraine headaches, multiple sclerosis, dementia.
- History of documented transient ischemic attacks within 6 months of screening.
- History of illicit drug or alcohol dependence/abuse within the past 12 months.
- Current use of antipsychotic, anticonvulsant, antidepressant (except for selective serotonin reuptake inhibitors) or anxiolytic medications (short acting anxiolytic medications are allowed if taken as needed with > 5 half-lives prior to assessments).
- History of chronic pain; current and/or chronic use of narcotic analgesia for > 21 days (total) within the last 3 months, or last dose less than 5 days prior to assessment.
Show all 18Show fewer
- Increased disease activity within 4 weeks of screening defined by an increase in SLEDAI by 3 points or more, exclusive of points from serologies, which prompts an increase in or new addition of SLE medications.
- History of a diagnosis of a primary psychiatric disorder preceding SLE diagnosis.
- Current active acute infections requiring antibiotics within 2 weeks of screening and chronic known infections (eg. hepatitis B, C, and/or HIV).
- Co-existing other autoimmune disease(s) other than autoimmune thyroid disease and secondary Sjogren's Syndrome.
- The presence of uncontrolled, severe hypertension, diabetes or heart disease.
- Impaired renal function with an estimated glomerular filtration rate (eGFR)< 30.
- Presence of any active medical condition that in the opinion of the investigator may contribute to cognitive and/or behavioral disturbances.
- Use of investigational drugs within 30 days or 5 half-lives before the study visit, whichever is longer.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
- Current treatment with cyclophosphamide, addition of belimumab within 4 months, addition of any disease modifying drug or biologic within 3 months of screening, and/or rituxan within 6 months.
- Limited fluency with English or Spanish that in the opinion of the investigator would limit the subject's performance on the assessments.
- Pregnant and/or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwell Health-Feinstein Insitute
Manhasset, New York, 11030
Bruce T Volpe, MD, 5165623384, bvolpe1@northwell.edu
Celina B. Fernandez, MS, 5165623646, cfernandez14@northwell.edu
About this study
Official title: Test of Whether Theta-gamma Coupling Present in Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus Acts as an Objective Marker for Cognitive Dysfunction
Patients with systemic lupus erythematosus (SLE) often experience a frustrating decline of their cognitive skills that includes considerable problems in attention, learning, and memory. This lupus-related cognitive dysfunction (termed SLE-CD) is recognized as the most prevalent of the nineteen neuropsychiatric SLE syndromes, as it affects up to 80% of patients and can significantly decrease their quality of life. The goal is to have tools that can be used for diagnosis and for monitoring responses after targeted interventions and therapies. This study will focus on electroencephalographic (EEG) signals, which will be detected noninvasively from scalp placed surface electrodes while the subjects are in a state of wakeful rest. Our hypothesis is that a subset of brain oscillations known as theta and gamma, and their co-modulation or coupling will be disrupted in SLE patients. This research protocol will subject patients with systemic lupus erythematosus (SLE) to scalp electroencephalography (EEG), with the goal of determining whether specific EEG patterns ('theta-gamma coupling') appear abnormal during wakeful-rest periods of 20 minutes. The investigators are interested in using scalp EEG because it is a standard, safe and robust technique for monitoring the electrophysiological activity of neurons in the cerebral cortex.
Read the detailed description
Patients will sit comfortably in a quiet room in a wakeful state and perform simple operations with toy blocks and look at three dimensional objects and answer some questions. The EEG electrodes fit into a custom-made cap and will effectively transmit wave activity just by touching the skin surface of the scalp. There is no need for electrode paste so at the end of the experiment the patient can remove the cap and go home. The entire procedure including fitting of the EEG cap will take about an hour.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest.
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest.Other
The proposed study is to determine whether EEG signals, namely theta-gamma coupling (TGC); The investigators are testing whether TGC can be used as a non-invasive novel biomarker in diagnosis and monitoring of insidious and difficult to detect cognitive dysfunction in SLE patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
A measure of the amount and relationship of theta and gamma waves in the EEG recording. The ability to perform the block building task and the ability to choose among unfolded three-dimensional objects.
Patient will build with toy blocks and three dimensional combination will suffice. The patient will also observe three dimensional objects - cubes, for example, that are unfolded and choose a matching object from an array that includes the object and three foils. EEG activity will be recorded during this period.
As the subjects will be fitted with noninvasive EEG caps (using dry electrodes that will contact the scalp directly) which will record the ongoing brain activity while the subjects, in a wakeful resting mode attempt to build with the toy blocks and analyze the three dimensional figures. This activity will go on for approximately 20 minutes.
The EEG signals will be analyzed to determine the theta gamma coupling (TGC).
Measured: Aim 1 will take the first 24 patients and they will spend an hour and a half undergoing EEG measuring TGC. For Aim 2 the patients will undergo EEG measuring TGC and predict the subsequent PET scan - which will occur under a separate protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start22 Apr 2024
- Primary completion23 Mar 2028 (estimated)
- Study completion23 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Volpe, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378736
- Sponsor's protocol ID
- 21-1027
- Status last verified
- Nov 2026
- First submitted
- 17 Apr 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will make recordings available to qualified researchers and pay attention to keep protected health information (PHI) confidential.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of Whether Theta-gamma Coupling Present in Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus Acts as an Objective Marker for Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT06378736
- Acronym / sponsor ID
- 21-1027
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 23 Mar 2028 (estimated)
- Study completion
- 23 Mar 2028 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with systemic lupus erythematosus (SLE) often experience a frustrating decline of their cognitive skills that includes considerable problems in attention, learning, and memory. This lupus-related cognitive dysfunction (termed SLE-CD) is recognized as the most prevalent of the nineteen neuropsychiatric SLE syndromes, as it affects up to 80% of patients and can significantly decrease their quality of life. The goal is to have tools that can be used for diagnosis and for monitoring responses after targeted interventions and therapies. This study will focus on electroencephalographic (EEG) signals, which will be detected noninvasively from scalp placed surface electrodes while the subjects are in a state of wakeful rest. Our hypothesis is that a subset of brain oscillations known as theta and gamma, and their co-modulation or coupling will be disrupted in SLE patients. This research protocol will subject patients with systemic lupus erythematosus (SLE) to scalp electroencephalography (EEG), with the goal of determining whether specific EEG patterns ('theta-gamma coupling') appear abnormal during wakeful-rest periods of 20 minutes. The investigators are interested in using scalp EEG because it is a standard, safe and robust technique for monitoring the electrophysiological activity of neurons in the cerebral cortex.
Detailed description
Patients will sit comfortably in a quiet room in a wakeful state and perform simple operations with toy blocks and look at three dimensional objects and answer some questions. The EEG electrodes fit into a custom-made cap and will effectively transmit wave activity just by touching the skin surface of the scalp. There is no need for electrode paste so at the end of the experiment the patient can remove the cap and go home. The entire procedure including fitting of the EEG cap will take about an hour.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty of the SLE subjects that have participated in prior brain imaging studies. The other 20 SLE subjects will be recruited from 2 ongoing observational studies of brain involvement in SLE.
Key inclusion criteria (7 listed)
- Must be able to understand and provide informed consent.
- Must be ≥18 and ≤65years of age.
- Must be female.
- Must fulfill the 1997 American College of Rheumatology (ACR) revised criteria for the diagnosis of SLE or the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) Criteria for SLE.
- Must have stable disease activity and medication doses for 4 weeks prior to screening. Stable disease activity is defined as no increase in disease activity requiring an increase or change in medications.
Key exclusion criteria (18 listed)
- Inability or unwillingness to give written informed consent or comply with study protocol.
- History of neurological diseases including, but not limited to, severe head injury or history of brain surgery, stroke, seizure, toxic exposure, mental retardation, migraine headaches, multiple sclerosis, dementia.
- History of documented transient ischemic attacks within 6 months of screening.
- History of illicit drug or alcohol dependence/abuse within the past 12 months.
- Current use of antipsychotic, anticonvulsant, antidepressant (except for selective serotonin reuptake inhibitors) or anxiolytic medications (short acting anxiolytic medications are allowed if taken as needed with > 5 half-lives prior to assessments).
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 |
|---|---|---|
| Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest.The proposed study is to determine whether EEG signals, namely theta-gamma coupling (TGC); The investigators are testing whether TGC can be used as a non-invasive novel biomarker in diagnosis and monitoring of insidious and difficult to detect cognitive dysfunction in SLE patients. | Other | – |
Primary outcome
A measure of the amount and relationship of theta and gamma waves in the EEG recording. The ability to perform the block building task and the ability to choose among unfolded three-dimensional objects.
Time frame: Aim 1 will take the first 24 patients and they will spend an hour and a half undergoing EEG measuring TGC. For Aim 2 the patients will undergo EEG measuring TGC and predict the subsequent PET scan - which will occur under a separate protocol.
Patient will build with toy blocks and three dimensional combination will suffice. The patient will also observe three dimensional objects - cubes, for example, that are unfolded and choose a matching object from an array that includes the object and three foils. EEG activity will be recorded during this period. As the subjects will be fitted with noninvasive EEG caps (using dry electrodes that will contact the scalp directly) which will record the ongoing brain activity while the subjects, in a wakeful resting mode attempt to build with the toy blocks and analyze the three dimensional figures. This activity will go on for approximately 20 minutes. The EEG signals will be analyzed to determine the theta gamma coupling (TGC).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. The investigators will make recordings available to qualified researchers and pay attention to keep protected health information (PHI) confidential.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Northwell Health 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 7 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruce T Volpe, MD (5165623384, bvolpe1@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A measure of the amount and relationship of theta and gamma waves in the EEG recording. The ability to perform the block building task and the ability to choose among unfolded three-dimensional objects. (time frame: Aim 1 will take the first 24 patients and they will spend an hour and a half undergoing EEG measuring TGC. For Aim 2 the patients will undergo EEG measuring TGC and predict the subsequent PET scan - which will occur under a separate protocol.). 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 6 Nov 2026.