Optimizing Stimulation Parameters for Electroconvulsive Therapy

N/ANot Yet RecruitingNCT07561307

University of Pennsylvania64 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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)

Electroencephalography - theta band power

Bilateral EEG over FP1 and FP2 zones, from which we will compute theta band power (in dB)

Electroencephalography - Brain Symmetry Index

Bilateral EEG over FP1 and FP2 zones, from which we will compute brain symmetry index (unitless)

Secondary Outcomes

Quick Inventory of Depression Self-Report

Depression symptom scale filled out by patient. Unitless, ranging from 0-27.

Time frame: 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

Catatonia rating scale conducted by clinical team. Unitless, ranging from 0-69.

Time frame: 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

Test of verbal fluency. Unit is number of words starting with a given letter provided in a one minute period.

3 word registration and recall

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.

Psychotic Depression Assessment Scale (PDAS)

Psychosis rating scale for patients with psychosis, to be administered by clinical team. Unitless, ranging from 0-44.

Time frame: 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

To be determined by clinical team. Unitless, ranging from 0-7.

Optimizing Stimulation Parameters for Electroconvulsive Therapy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts