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Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy (DNS-ECT)

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ClinicalTrials.gov Identifier: NCT05905705
Recruitment Status : Recruiting
First Posted : June 15, 2023
Last Update Posted : June 15, 2023
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
MohammadMehdi Kafashan, Washington University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment
Treatment Resistant Depression Diagnostic Test: Electroencephalography (EEG) Diagnostic Test: Quantitative Measurements of Sleep Microstructure

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy
Actual Study Start Date : March 7, 2023
Estimated Primary Completion Date : July 31, 2027
Estimated Study Completion Date : July 31, 2027

Resource links provided by the National Library of Medicine


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

Outcome Measures
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Primary Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Treatment-Resistant Depression (TRD), unipolar major depressive disorder or bipolar depression
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05905705


Contacts
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Contact: Alec Hester 314-273-0901 alech@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine/Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Alec Hester    314-273-0901    alech@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: MohammadMehdi Kafashan Washington University School of Medicine in St. Louis
More Information
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Publications:

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Responsible Party: MohammadMehdi Kafashan, Instructor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT05905705    
Other Study ID Numbers: 202204161
K01MH128663 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2023    Key Record Dates
Last Update Posted: June 15, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder, Treatment-Resistant
Depressive Disorder
Mood Disorders
Mental Disorders