NCT06378736

Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-01-22
• Primary completion: 2026-03-23
• Completion: 2026-03-23
• First posted: 2024-04-22
• Last updated: 2024-04-29

Locations

1 site across 1 country: United States