Optimizing Stimulation Parameters for Electroconvulsive Therapy

NCT07561307 | Not Yet Recruiting

• 1 other identifier: 26-6396
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catatonia; Depression - Major Depressive Disorder

Keywords

electroconvulsive therapy

Outcome Measures

Primary Outcomes (4)

• Brain hemodynamics

  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

  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

  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

  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.

Secondary Outcomes (6)

• Quick Inventory of Depression Self-Report

  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

  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

  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

  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)

  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

Study Arms (4)

Index: Standard titration table

ACTIVE COMPARATOR

Patients are treated with ECT using titration table 1 (alternating increases in frequency and duration)

Procedure: Electroconvulsive Therapy

Index: Frequency-then-duration

EXPERIMENTAL

ECT provided using Table 2, frequency uptitration followed by duration uptitration

Procedure: Electroconvulsive Therapy

Index: Duration then Frequency

EXPERIMENTAL

ECT provided using Table 3, duration titration then frequency titration

Procedure: Electroconvulsive Therapy

Maintenance

OTHER

Internal cross-over arm in which patients undergo 8 sessions using 8 randomized sub-convulsive stimulation protocols

Procedure: Electroconvulsive Therapy

Interventions

Electroconvulsive Therapy PROCEDURE

Electrical stimulation under anesthesia

Index: Duration then Frequency; Index: Frequency-then-duration; Index: Standard titration table; Maintenance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Catatonia

Interventions

Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Zachary Rosenthal, MD PhD

CONTACT

19738976511; Zachary.Rosenthal@pennmedicine.upenn.edu

Mario Cristancho, MD

CONTACT

marioc@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: All patients are treated with ECT using different stimulation parameters

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)