Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy
DNS-ECT
2 other identifiers
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2023
CompletedFirst Submitted
Initial submission to the registry
June 6, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
March 12, 2026
March 1, 2026
4.4 years
June 6, 2023
March 11, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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
Up to 4 weeks during patients ECT treatment course
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.
Up to 4 weeks during patients ECT treatment course
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).
Up to 4 weeks during patients ECT treatment course
Interventions
High-density EEG will be acquired during resting wakefulness before each ECT session.
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.
Eligibility Criteria
Treatment-Resistant Depression (TRD), unipolar major depressive disorder or bipolar depression
You may qualify if:
- 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.
You may not qualify if:
- Diagnoses of schizophrenia or schizoaffective disorders.
- Subjects who are unable to tolerate the Dreem device for sleep recordings will be excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Related Publications (3)
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: 36405897BACKGROUNDHill 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: 32853716BACKGROUNDKafashan 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: 40054874DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MohammadMehdi Kafashan
Washington University School of Medicine in St. Louis
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 15, 2023
Study Start
March 7, 2023
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
March 12, 2026
Record last verified: 2026-03