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Optimizing Stimulation Parameters for Electroconvulsive Therapy (PRESTO)

23. April 2026 aktualisiert von: Zach Rosenthal, University of Pennsylvania

Parameter Refinement for ECT Stimulation and Titration Optimization

The goal of this clinical trial is to improve how electroconvulsive therapy (ECT) stimulation settings are chosen. Researchers will use real-time brain monitoring to measure both seizures and a recently identified brain event called cortical spreading depolarization (CSD).

The main questions it aims to answer are:

What is the best way to increase ECT stimulation settings? How do different pulse settings affect the brain's response? Can certain settings produce CSD without causing a seizure?

Participants already receiving ECT as part of their care will take part. They will be assigned to one of two groups:

Index ECT group: Participants starting ECT will receive different standard titration approaches.

Maintenance ECT group: Participants receiving ongoing ECT will undergo a brief, low-dose stimulation test before treatment.

All participants will be monitored using brain physiology (EEG and blood flow) and symptom scales during treatment.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This is an exploratory, single-center open-label clinical trial at Pennsylvania Hospital (PAH) intended to optimize stimulation settings for electroconvulsive therapy (ECT), guided by real-time monitoring of both seizure and a recently discovered postictal event: cortical spreading depolarization (CSD). We will address three key questions: 1. What is the best strategy for up-titrating settings for ECT?; 2. How do individual pulse parameters impact brain evoked response?; 3. Are there stimulation settings that directly induce CSD waves without seizure?

This study will take place in the context of routine treatments for patients already consenting to receive ECT for a wide range of clinical indications. Patients will be enrolled in one of two arms:

  1. Index Titration Arm: Patients coming in for initial index ECT courses (acute phase) will be randomized to one of several stimulation parameter titration tables while receiving otherwise routine ECT care.
  2. Maintenance Arm: In clinically stable patients receiving monthly maintenance ECT, a sub-convulsive stimulation settings ramp will be performed under anesthesia immediately preceding their regular ECT treatment.

All patients being treated with ECT at PAH are eligible for this study. Outcomes will include non-invasive monitoring of brain hemodynamics and EEG as well as clinical symptom scales.

Studientyp

Interventionell

Einschreibung (Geschätzt)

64

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Any patients being treated with electroconvulsive therapy at Pennsylvania Hospital who are willing and able to participate are eligible to be subjects in this study.

Exclusion Criteria:

  1. They are unwilling or unable to consent first to the SWEET COMBO protocol for optical monitoring during ECT
  2. Clinically significant psychiatric comorbidity as determined by clinical interview and in the opinion of the Investigator and clinical team would alter the risk/benefit of the study
  3. History of poor response to ECT treatment in the opinion of the Investigator and clinical team that would alter the risk/benefit of the study

  4. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise, interfere with, limit, affect or reduce the:

    1. subject's ability to participate safely in the study
    2. integrity of the data or
    3. subject's ability to complete the full duration of the study.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Index: Standard titration table
Patients are treated with ECT using titration table 1 (alternating increases in frequency and duration)
Verfahren: Electroconvulsive Therapy
Electrical stimulation under anesthesia
Experimental: Index: Frequency-then-duration
ECT provided using Table 2, frequency uptitration followed by duration uptitration
Verfahren: Electroconvulsive Therapy
Electrical stimulation under anesthesia
Experimental: Index: Duration then Frequency
ECT provided using Table 3, duration titration then frequency titration
Verfahren: Electroconvulsive Therapy
Electrical stimulation under anesthesia
Sonstiges: Maintenance
Internal cross-over arm in which patients undergo 8 sessions using 8 randomized sub-convulsive stimulation protocols
Verfahren: Electroconvulsive Therapy
Electrical stimulation under anesthesia

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Brain hemodynamics
Zeitfenster: Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm.
Functional near infrared spectroscopy imaging will be performed during each ECT treatment, from which we will extract oxy- and deoxyhemoglobin concentrations (in mM) over time.
Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm.
Electroencephalography - Seizure Duration
Zeitfenster: Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm.
Bilateral EEG over FP1 and FP2 zones, from which we will compute seizure duration (in seconds)
Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm.
Electroencephalography - theta band power
Zeitfenster: Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm.
Bilateral EEG over FP1 and FP2 zones, from which we will compute theta band power (in dB)
Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm.
Electroencephalography - Brain Symmetry Index
Zeitfenster: Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm.
Bilateral EEG over FP1 and FP2 zones, from which we will compute brain symmetry index (unitless)
Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Quick Inventory of Depression Self-Report
Zeitfenster: Administered pre-procedurally at baseline and once weekly for index arm patients (for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.
Depression symptom scale filled out by patient. Unitless, ranging from 0-27.
Administered pre-procedurally at baseline and once weekly for index arm patients (for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.
Bush Francis Catatonia Rating Scale
Zeitfenster: Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.
Catatonia rating scale conducted by clinical team. Unitless, ranging from 0-69.
Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.
Single Letter Fluency
Zeitfenster: Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.
Test of verbal fluency. Unit is number of words starting with a given letter provided in a one minute period.
Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.
3 word registration and recall
Zeitfenster: Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.
Test of short term memory. Unit is number (out of 3) words registered and repeated back at 0 minutes, and the same at 3 minutes delay.
Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.
Psychotic Depression Assessment Scale (PDAS)
Zeitfenster: Administered pre-procedurally at baseline and once weekly for index arm patients (for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients
Psychosis rating scale for patients with psychosis, to be administered by clinical team. Unitless, ranging from 0-44.
Administered pre-procedurally at baseline and once weekly for index arm patients (for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients
Clinical Global Impressions Scale for Severity and Improvement
Zeitfenster: Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.
To be determined by clinical team. Unitless, ranging from 0-7.
Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Pennsylvania

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

30. Juni 2029

Studienabschluss (Geschätzt)

30. Juni 2030

Studienanmeldedaten

Zuerst eingereicht

25. März 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. April 2026

Zuerst gepostet (Tatsächlich)

1. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 26-6396

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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