Clinical trial NCT05905705: Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy
Official title: Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Treatment Resistant Depression
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment-Resistant Depression (TRD), unipolar major depressive disorder or bipolar depression

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.

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.

Eligibility 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.

Primary outcomes:
measure: Slow wave activity (SWA) during non-rapid eye movement sleep (NREM) stage N2/N3
timeFrame: Up to 4 weeks during patients ECT treatment course
measure: Graph-based neural connectivity measure of local efficiency of information transfer (Elocal) during wakefulness
timeFrame: Up to 4 weeks during patients ECT treatment course
measure: Graph-based neural connectivity measure of global information transfer (Eglobal) during ECT-induced seizure
timeFrame: Up to 4 weeks during patients ECT treatment course
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine/Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine in St. Louis
name: MohammadMehdi Kafashan
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.