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

March 11, 2026 updated by: MohammadMehdi Kafashan, Washington University School of Medicine
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine/Barnes-Jewish Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Treatment-Resistant Depression (TRD), unipolar major depressive disorder or bipolar depression

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 4 weeks during patients ECT treatment course
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.
Up to 4 weeks during patients ECT treatment course
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).
Up to 4 weeks during patients ECT treatment course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute of Mental Health (NIMH)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202204161
  • K01MH128663 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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