Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy

NCT ID: NCT05905705

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-07

Study Completion Date

2027-07-31

Brief Summary

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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

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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.

Conditions

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Treatment Resistant Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Electroencephalography (EEG)

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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MohammadMehdi Kafashan

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MohammadMehdi Kafashan

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine in St. Louis

Locations

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Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Robby Greenspan

Role: CONTACT

314-273-6129

MohammadMehdi Kafashan

Role: CONTACT

314-273-8848

Facility Contacts

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Robby Greenspan

Role: primary

314-273-6129

References

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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.

Reference Type BACKGROUND
PMID: 36405897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32853716 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40054874 (View on PubMed)

Other Identifiers

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K01MH128663

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202204161

Identifier Type: -

Identifier Source: org_study_id

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