Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy

Treatment Resistant Depression Clinical Trial

— DNS-ECT  

Official title:

Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905705
• Other study ID #: 202204161
• Secondary ID: K01MH128663
• Status: Recruiting
• Start date: March 7, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: November 2023
• Source: Washington University School of Medicine
• Contact: Robby Greenspan
• Phone: 314-273-6129
• Email: greenspan[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Diagnostic Test:
• Electroencephalography (EEG)
High-density EEG will be acquired during resting wakefulness before each ECT session.
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine/Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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