Recording brain activity in patients with lupus

Test of Whether Theta-gamma Coupling Present in Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus Acts as an Objective Marker for Cognitive Dysfunction

This study tests how brain activity in lupus patients relates to thinking problems by using a special cap to record their brain waves while they do simple tasks.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Northwell Health (Academic / other)
• Drugs / interventions: belimumab, cyclophosphamide, prednisone
• Locations: 1 site (Manhasset, New York)
• Trial ID: NCT06378736 on ClinicalTrials.gov

What this trial studies

This study investigates cognitive dysfunction in patients with systemic lupus erythematosus (SLE) by recording electroencephalographic (EEG) signals. Participants will engage in simple tasks while their brain activity is monitored using a noninvasive EEG cap. The focus is on identifying disruptions in specific brain oscillations, particularly theta and gamma waves, which may correlate with cognitive decline in SLE patients. The findings aim to enhance diagnostic tools and monitor treatment responses for cognitive issues associated with lupus.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 to 65 who have a confirmed diagnosis of systemic lupus erythematosus and stable disease activity.

Not a fit: Patients with significant neurological diseases or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and monitoring tools for cognitive dysfunction in lupus patients.

How similar studies have performed: While the approach of using EEG in lupus patients is relatively novel, similar studies in other conditions have shown promise in understanding cognitive dysfunction.

Eligibility 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.

Where this trial is running

Manhasset, New York

• Northwell Health-Feinstein Insitute — Manhasset, New York, United States (Recruiting)

Study contacts

• Study coordinator: Bruce T Volpe, MD

Conditions Systemic Lupus Erythematosus