Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 65 Years
Gender Female
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Must be able to understand and provide informed consent. 2. Must be ≥18 and ≤65years of age. 3. Must be female. 4. 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. 5. 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. 6. Must be on a corticosteroid dose that is ≤ prednisone 10 mg daily, or equivalent. 7. Aim 1 ONLY: Must have demonstrated significantly increased metabolism in the hippocampus, temporal or parietal lobes on prior fluoro-deoxy glucose (FDG)-PET imaging.

Exclusion Criteria:

1. Inability or unwillingness to give written informed consent or comply with study protocol. 2. 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. 3. History of documented transient ischemic attacks within 6 months of screening. 4. History of illicit drug or alcohol dependence/abuse within the past 12 months. 5. 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). 6. 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. 7. 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. 8. History of a diagnosis of a primary psychiatric disorder preceding SLE diagnosis. 9. Current active acute infections requiring antibiotics within 2 weeks of screening and chronic known infections (eg. hepatitis B, C, and/or HIV). 10. Co-existing other autoimmune disease(s) other than autoimmune thyroid disease and secondary Sjogren's Syndrome. 11. The presence of uncontrolled, severe hypertension, diabetes or heart disease. 12. Impaired renal function with an estimated glomerular filtration rate (eGFR)< 30. 13. Presence of any active medical condition that in the opinion of the investigator may contribute to cognitive and/or behavioral disturbances. 14. Use of investigational drugs within 30 days or 5 half-lives before the study visit, whichever is longer. 15. 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. 16. 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. 17. Limited fluency with English or Spanish that in the opinion of the investigator would limit the subject's performance on the assessments. 18. Pregnant and/or lactating women.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06378736
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Northwell Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Northwell Health-Feinstein Insitute, Manhasset, New York

Status

Recruiting

Address

Northwell Health-Feinstein Insitute

Manhasset, New York, 11030

Site Contact

Bruce T Volpe, MD

[email protected]

516-562-3384