Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy

Recruiting

• Conditions: Treatment Resistant Depression

• Registration Number: NCT05905705
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Electroconvulsive therapy (ECT) alleviates treatment-resistant depression (TRD) through repeated generalized seizures. The goal of this study is to evaluate how ECT impacts sleep-wake regulation and efficiency of information transfer in functional networks in different states of arousal.

Detailed Description

Graph-based network analyses of electroencephalographic (EEG) signals allow characterization of functional networks. The robustness of local networks to disruption is quantified as local efficiency (Elocal), while network integration is quantified as global information transfer (Eglobal).

Aim 1: Assess relationships between sleep slow-wave activity (SWA) and awake Elocal over the course of ECT.

Aim 2: Quantify relationships between depression severity and awake Elocal over the course of ECT.

Study Timeline

• Study Start: 2023-03-07
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Referral for initial ECT index course for Treatment-Resistant Depression (TRD), unipolar major depressive disorder or bipolar depression. Historic failure of response or remission to at least two antidepressant medications of sufficient dose and duration will be used for TRD diagnostic.

Exclusion Criteria

• Diagnoses of schizophrenia or schizoaffective disorders.
• Subjects who are unable to tolerate the Dreem device for sleep recordings will be excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Slow wave activity (SWA) during non-rapid eye movement sleep (NREM) stage N2/N3	Up to 4 weeks during patients ECT treatment course	Total power of EEG slow waves per minute present during N2/N3 sleep
Graph-based neural connectivity measure of local efficiency of information transfer (Elocal) during wakefulness	Up to 4 weeks during patients ECT treatment course	Elocal will be calculated as the average inverse shortest path length among neighbors of a node within the network. Nodes will be constructed based on 5-minute recordings of eyes closed wakefulness theta band (4-8 Hz) EEG.
Graph-based neural connectivity measure of global information transfer (Eglobal) during ECT-induced seizure	Up to 4 weeks during patients ECT treatment course	Eglobal will be calculated as the average inverse shortest path length between node pairs in the networks. Nodes will be constructed based on ECT-induced seizure EEG data within the alpha band (8-13 Hz).

Trial Locations

Locations (1)

Washington University School of Medicine/Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States