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NCT Number: NCT05905705

Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy

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.

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Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Robby Greenspan

CONTACT

[email protected]

314-273-6129

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroencephalography (EEG)

Diagnostic Test

High-density EEG will be acquired during resting wakefulness before each ECT session.

Quantitative Measurements of Sleep Microstructure

Diagnostic Test

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 outcomes

  1. 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

    Total power of EEG slow waves per minute present during N2/N3 sleep

  2. 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

    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.

  3. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

MohammadMehdi Kafashan

CONTACT

[email protected]

314-273-8848

Robby Greenspan

CONTACT

[email protected]

314-273-6129

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: DNS-ECT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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