Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378736
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-17
Brief Title:
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None