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

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05905705
Collaborator
National Institute of Mental Health (NIMH) (NIH)
50
1
52.8
0.9

Study Details

Study Description

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 Phase
  • 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

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

Outcome Measures

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Washington University School of Medicine/Barnes-Jewish Hospital Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: MohammadMehdi Kafashan, Washington University School of Medicine in St. Louis

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
MohammadMehdi Kafashan, Instructor, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05905705
Other Study ID Numbers:
  • 202204161
  • K01MH128663
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2023