NCT04451135

CET- REM (Correlating ECT Response to EEG Markers)

Correlating Electroconvulsive Therapy Response to Electroencephalographic Ictal Complexes and Postictal Markers

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single-center study to determine the relationship between changes in depression symptoms and electroencephalographic (EEG) patterns induced by electroconvulsive therapy (ECT)

Detailed description

Electroconvulsive therapy (ECT) is an effective treatment for many psychiatric illnesses, including major depressive disorder. While effective, objective markers have not been developed to predict clinical outcome trajectories following ECT. This is important given the risks and costs incurred during a full treatment course. Electroencephalography (EEG) is typically employed to monitor the generation and termination of ECT-induced seizures but leverage of markers toward prognostication remains a future goal. The investigators have characterized two distinct EEG patterns associated with ECT-induced generalized seizures and have two sleep markers that may serve as markers for predicting response to treatment. Central Positive Complexes (CPCs) are large ictal complexes with a scalp topology of voltage declining from the top of the head. CPCs are localized to cortical areas that are involved in the formation of sleep spindles and slow wave sleep. A pattern of low-voltage activity, known as post-ictal generalized electroencephalographic suppression (PGES), is frequently used to document termination of these seizures. Additionally, two EEG markers of sleep microstructure may have utility given their association with synaptic plasticity, a process presumably invoked over the course of ECT-induced recovery from psychiatric illness as pathologic neural circuitry undergoes reconfiguration. These two markers, sleep spindles and slow waves show altered expression patterns in patients with psychiatric disorders, and thus may be useful as objective markers of ECT responsiveness. None of the above EEG markers have been explored for an association to interval changes in disease severity over the course of ECT. This project will incisively probe the relationships between temporal trajectories of major depressive disorder severity and longitudinal measurements of ictal and postictal EEG markers.

Conditions

• ECT
• Treatment Resistant Depression

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Electroencephalographic (EEG)	EEG on nights after ECT session will be recorded using the DREEM device. Sleep EEG data will also be acquired for a minimum of one night prior to the first ECT session, providing a true baseline measure. The DREEM device allows continuous recording of multichannel EEG
DIAGNOSTIC_TEST	Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16)	The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) is a measure of depression symptom severity that has been validated for clinical and research use53. It is a standard self-report measurement completed by patients prior to each ECT session
DIAGNOSTIC_TEST	Ictal Electroencephalographic (EEG) Measurements	A high-density 65-electrode EEG scalp electrode net (EGI/Philips) with Elefix conductive gel injected within Ag/AgCl electrode sensors is utilized to monitor brain activity during the ictal period
DIAGNOSTIC_TEST	Post-Ictal Electroencephalographic (EEG) Suppression Measurements	A board-certified epileptologist will review all seizures to assess seizure parameters, including duration of seizure and interval of PGES. Preprocessing of the PGES periods will be accomplished with band-pass filtering from 2 to 30 Hz with 1st order Butterworth filters.

Timeline

• Start date: 2020-10-09
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2020-06-30
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States