Optimizing Stimulation Parameters for Electroconvulsive Therapy (PRESTO)
23. dubna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Detailní popis
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:
- 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.
- 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.
Typ studie
Intervenční
Zápis (Odhadovaný)
64
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Zachary Rosenthal, MD PhD
- Telefonní číslo: 19738976511
- E-mail: Zachary.Rosenthal@pennmedicine.upenn.edu
Studijní záloha kontaktů
- Jméno: Mario Cristancho, MD
- E-mail: marioc@pennmedicine.upenn.edu
Studijní místa
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Spojené státy, 19146
- Pennsylvania Hospital
-
Kontakt:
- Zachary Rosenthal
- Telefonní číslo: 9738976511
- E-mail: Zachary.Rosenthal@pennmedicine.upenn.edu
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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:
- They are unwilling or unable to consent first to the SWEET COMBO protocol for optical monitoring during ECT
- 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
- 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
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:
- subject's ability to participate safely in the study
- integrity of the data or
- subject's ability to complete the full duration of the study.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Index: Standard titration table
Patients are treated with ECT using titration table 1 (alternating increases in frequency and duration)
|
Electrical stimulation under anesthesia
|
|
Experimentální: Index: Frequency-then-duration
ECT provided using Table 2, frequency uptitration followed by duration uptitration
|
Electrical stimulation under anesthesia
|
|
Experimentální: Index: Duration then Frequency
ECT provided using Table 3, duration titration then frequency titration
|
Electrical stimulation under anesthesia
|
|
Jiný: Maintenance
Internal cross-over arm in which patients undergo 8 sessions using 8 randomized sub-convulsive stimulation protocols
|
Electrical stimulation under anesthesia
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Brain hemodynamics
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Quick Inventory of Depression Self-Report
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. července 2026
Primární dokončení (Odhadovaný)
30. června 2029
Dokončení studie (Odhadovaný)
30. června 2030
Termíny zápisu do studia
První předloženo
25. března 2026
První předloženo, které splnilo kritéria kontroly kvality
23. dubna 2026
První zveřejněno (Aktuální)
1. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. dubna 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Neurologické projevy
- Nemoci nervového systému
- Symptomy chování
- Neurobehaviorální projevy
- Patologické stavy, příznaky a symptomy
- Chování
- Příznaky a symptomy
- Katatonie
- Disciplíny a činnosti chování
- Kvisulská terapie
- Psychiatrické somatické terapie
- Electroshock
- Psychologické techniky
- Elektrokonvulsivní terapie
Další identifikační čísla studie
- 26-6396
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