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- Essai clinique NCT04451135
CET- REM (corrélation de la réponse ECT aux marqueurs EEG)
Corréler la réponse de la thérapie électroconvulsive aux complexes ictaux électroencéphalographiques et aux marqueurs postictaux
Single-center study to determine the relationship between changes in depression symptoms and electroencephalographic (EEG) patterns induced by electroconvulsive therapy (ECT)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Electroconvulsive therapy (ECT) is an effective treatment for many psychiatric illnesses, including major depressive disorder. While effective, objective markers have not been developed to predict clinical outcome trajectories following ECT. This is important given the risks and costs incurred during a full treatment course. Electroencephalography (EEG) is typically employed to monitor the generation and termination of ECT-induced seizures but leverage of markers toward prognostication remains a future goal. The investigators have characterized two distinct EEG patterns associated with ECT-induced generalized seizures and have two sleep markers that may serve as markers for predicting response to treatment. Central Positive Complexes (CPCs) are large ictal complexes with a scalp topology of voltage declining from the top of the head. CPCs are localized to cortical areas that are involved in the formation of sleep spindles and slow wave sleep. A pattern of low-voltage activity, known as post-ictal generalized electroencephalographic suppression (PGES), is frequently used to document termination of these seizures. Additionally, two EEG markers of sleep microstructure may have utility given their association with synaptic plasticity, a process presumably invoked over the course of ECT-induced recovery from psychiatric illness as pathologic neural circuitry undergoes reconfiguration. These two markers, sleep spindles and slow waves show altered expression patterns in patients with psychiatric disorders, and thus may be useful as objective markers of ECT responsiveness. None of the above EEG markers have been explored for an association to interval changes in disease severity over the course of ECT. This project will incisively probe the relationships between temporal trajectories of major depressive disorder severity and longitudinal measurements of ictal and postictal EEG markers.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Missouri
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St Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine/Barnes-Jewish Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 18 years or greater
- Referral for ECT index course for treatment-resistant depression (unipolar major depressive disorder or bipolar depression), major depressive disorder with psychotic symptoms, schizophrenia or schizoaffective being treated for a depressed episode, unspecified depression
Exclusion Criteria:
- Schizophrenia or schizoaffective disorder not being treated for a depressed episode.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Patients souffrant de dépression résistante au traitement
|
EEG on nights after ECT session will be recorded using the DREEM device. Sleep EEG data will also be acquired for a minimum of one night prior to the first ECT session, providing a true baseline measure. The DREEM device allows continuous recording of multichannel EEG The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) is a measure of depression symptom severity that has been validated for clinical and research use53. It is a standard self-report measurement completed by patients prior to each ECT session A high-density 65-electrode EEG scalp electrode net (EGI/Philips) with Elefix conductive gel injected within Ag/AgCl electrode sensors is utilized to monitor brain activity during the ictal period A board-certified epileptologist will review all seizures to assess seizure parameters, including duration of seizure and interval of PGES. Preprocessing of the PGES periods will be accomplished with band-pass filtering from 2 to 30 Hz with 1st order Butterworth filters. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Interval change in Quick Inventory of Depressive Symptomatology-16 Item Self Report (QIDS-SR16) between ECT sessions.
Délai: Up to 8 weeks during patients ECT treatment course
|
16 item Self-report questionnaire that best describes the participant's depressive symptoms over the last seven days. Scale: 0=never or do not, 3=nearly all the time, or the highest level of time listed on the question. |
Up to 8 weeks during patients ECT treatment course
|
|
Duration of Central Positive Complexes during ECT treatments.
Délai: Up to 8 weeks during patients ECT treatment course
|
Total time (in seconds) during the ictal period for which CPCs are present in the EEG immediately following seizure induction until termination of the seizure. Range of values: 0 - 300 seconds |
Up to 8 weeks during patients ECT treatment course
|
|
Duration of PGES during ECT treatments.
Délai: Up to 8 weeks during patients ECT treatment course
|
Total time (in seconds) during the postictal period for which PGES is present in the EEG immediately following seizure termination for up to 5 minutes. Range of values: 0 - 300 seconds |
Up to 8 weeks during patients ECT treatment course
|
|
Density of EEG sleep spindles during non-rapid eye movement (NREM) stages N2 on evenings following ECT treatments.
Délai: Up to 8 weeks during patients ECT treatment course
|
The total number of EEG sleep spindles per minute present during N2 sleep. Range of values: 0 - 60 spindles/min |
Up to 8 weeks during patients ECT treatment course
|
|
Slow wave activity (SWA) during N3 sleep on evenings following ECT treatments
Délai: Up to 8 weeks during patients ECT treatment course
|
Total power of EEG slow waves per minute present during the first identified cycle of N3 sleep Range of values: 0 - 50 dB/min |
Up to 8 weeks during patients ECT treatment course
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: MohammadMehdi Kafashan, Washington University School of Medicine
Publications et liens utiles
Publications générales
- Lopez J, Hoffmann R, Armitage R. Reduced sleep spindle activity in early-onset and elevated risk for depression. J Am Acad Child Adolesc Psychiatry. 2010 Sep;49(9):934-43. doi: 10.1016/j.jaac.2010.05.014. Epub 2010 Jul 24.
- Kho KH, van Vreeswijk MF, Simpson S, Zwinderman AH. A meta-analysis of electroconvulsive therapy efficacy in depression. J ECT. 2003 Sep;19(3):139-47. doi: 10.1097/00124509-200309000-00005.
- Kafashan M, Brian Hickman L, Labonte AK, Huels ER, Maybrier H, Guay CS, Subramanian S, Farber NB, Ching S, Hogan RE, Kelz MB, Avidan MS, Mashour GA, Palanca BJA. Quiescence during burst suppression and postictal generalized EEG suppression are distinct patterns of activity. Clin Neurophysiol. 2022 Oct;142:125-132. doi: 10.1016/j.clinph.2022.07.493. Epub 2022 Jul 30.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 202006108
Informations sur les médicaments et les dispositifs, documents d'étude
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