RECRUITING

Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-01-22

Study Completion:2026-03-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06378736

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Bruce T Volpe, MD

CONTACT

5165623384

bvolpe1@northwell.edu

Study Locations (Sites)

Northwell Health-Feinstein Insitute

Manhasset, New York, 11030

United States

Collaborators and Investigators

Sponsor: Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-22

Study Completion Date2026-03-23

Study Record Updates

Study Start Date2024-01-22

Study Completion Date2026-03-23

Terms related to this study

Additional Relevant MeSH Terms

Systemic Lupus Erythematosus