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Test of Whether Theta-gamma Coupling Present in Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus Acts as an Objective Marker for Cognitive Dysfunction
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.
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.
Age
18 - 65 years
Sex
FEMALE
Healthy Volunteers
No
Northwell Health-Feinstein Insitute
Manhasset, New York, United States
Start Date
January 22, 2024
Primary Completion Date
March 23, 2026
Completion Date
March 23, 2026
Last Updated
April 29, 2024
40
ESTIMATED participants
Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest.
OTHER
Lead Sponsor
Northwell Health
NCT06647069
NCT07371468
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View ClinicalTrials.gov Terms and ConditionsNCT06333483