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
Northwell Health·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest.
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
Northwell Health
Location
Manhasset, United States of America
Timeline & enrollment
Phase
N/A
Start date
Jan 22, 2024
End date
Mar 23, 2026
Enrollment
40 participants
Primary outcome

A measure of the amount and relationship of theta and gamma waves in the EEG recording. The ability to perform the block building task and the ability to choose among unfolded three-dimensional objects.

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.

ICD-10 classifications
Systemic lupus erythematosusSystemic lupus erythematosus, unspecifiedLupus erythematosusSystemic lupus erythematosus with organ or system involvementOther forms of systemic lupus erythematosus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06378736
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06378736 through Pure Global AI's free database. This phase not specified trial is sponsored by Northwell Health and is currently Recruiting. The study focuses on Systemic Lupus Erythematosus. Target enrollment is 40 participants.

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