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Recruiting NCT05905705

Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy

— Observational Treatment Resistant Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electroencephalography (EEG), Quantitative Measurements of Sleep Microstructure.
Who it may be relevant to
Registry conditions: Treatment Resistant Depression. Basic parameters: 21 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test Electroencephalography (EEG)
    High-density EEG will be acquired during resting wakefulness before each ECT session.
  • Diagnostic test Quantitative Measurements of Sleep Microstructure
    Overnight sleep EEG will be recorded one day before each ECT session using the DREEM device. The DREEM device allows continuous recording of multichannel EEG.

Primary outcome measures

  • Slow wave activity (SWA) during non-rapid eye movement sleep (NREM) stage N2/N3 [Time frame: Up to 4 weeks during patients ECT treatment course]
  • Graph-based neural connectivity measure of local efficiency of information transfer (Elocal) during wakefulness [Time frame: Up to 4 weeks during patients ECT treatment course]
  • Graph-based neural connectivity measure of global information transfer (Eglobal) during ECT-induced seizure [Time frame: Up to 4 weeks during patients ECT treatment course]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Washington University School of Medicine/Barnes-Jewish Hospital — St Louis

Publications

  • Subramanian S, Labonte AK, Nguyen T, Luong AH, Hyche O, Smith SK, Hogan RE, Farber NB, Palanca BJA, Kafashan M; CET-REM Study Group. Correlating electroconvulsive therapy response to electroencephalographic markers: Study protocol. Front Psychiatry. 2022 Nov 3;13:996733. doi: 10.3389/fpsyt.2022.996733. eCollection 2022. PMID 36405897
  • Hill AT, Zomorrodi R, Hadas I, Farzan F, Voineskos D, Throop A, Fitzgerald PB, Blumberger DM, Daskalakis ZJ. Resting-state electroencephalographic functional network alterations in major depressive disorder following magnetic seizure therapy. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Jun 8;108:110082. doi: 10.1016/j.pnpbp.2020.110082. Epub 2020 Aug 24. PMID 32853716
  • Kafashan M, Lebovitz L, Greenspan R, Zhao S, Kim T, Husain M, Hershey T, Cristancho P, Hogan RE, Palanca BJA, Farber NB; DNS-ECT Study Team. Investigating the impact of electroconvulsive therapy on brain networks and sleep: an observational study protocol. BMJ Open. 2025 Mar 7;15(3):e098859. doi: 10.1136/bmjopen-2025-098859. PMID 40054874

Identifiers

NCT: NCT05905705 · 202204161 · K01MH128663

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗