Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-65
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Diagnoses of schizophrenia or schizoaffective disorders.

Subjects who are unable to tolerate the Dreem device for sleep recordings will be excluded from the study.

Trial population

Treatment-Resistant Depression (TRD), unipolar major depressive disorder or bipolar depression

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Slow wave activity (SWA) during non-rapid eye movement sleep (NREM) stage N2/N3

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

Time frame
Up to 4 weeks during patients ECT treatment course
2

Graph-based neural connectivity measure of local efficiency of information transfer (Elocal) during wakefulness

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.

Time frame
Up to 4 weeks during patients ECT treatment course
3

Graph-based neural connectivity measure of global information transfer (Eglobal) during ECT-induced seizure

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).

Time frame
Up to 4 weeks during patients ECT treatment course

Secondary outcomes

Other outcomes

Sponsors and contacts

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Washington University School of Medicine

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator