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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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. 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

• Aim 1 ONLY: Must have demonstrated significantly increased metabolism in the hippocampus, temporal or parietal lobes on prior fluoro-deoxy glucose (FDG)-PET imaging.

Locations
United States
New York
Northwell Health-Feinstein Insitute
RECRUITING
Manhasset
Contact Information
Primary
Bruce T Volpe, MD
bvolpe1@northwell.edu
5165623384
Time Frame
Start Date: 2024-01-22
Estimated Completion Date: 2026-03-23
Participants
Target number of participants: 40
Related Therapeutic Areas
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov