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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Index: Standard titration table | Active Comparator | Patients are treated with ECT using titration table 1 (alternating increases in frequency and duration) |
|
| Index: Frequency-then-duration | Experimental | ECT provided using Table 2, frequency uptitration followed by duration uptitration |
|
| Index: Duration then Frequency | Experimental | ECT provided using Table 3, duration titration then frequency titration |
|
| Maintenance | Other | Internal cross-over arm in which patients undergo 8 sessions using 8 randomized sub-convulsive stimulation protocols |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroconvulsive Therapy | Procedure | Electrical stimulation under anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depression Self-Report | 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 |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zachary Rosenthal, MD PhD | Contact | 19738976511 | Zachary.Rosenthal@pennmedicine.upenn.edu | |
| Mario Cristancho, MD | Contact | marioc@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19146 | United States |
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| ID | Term |
|---|---|
| D002389 | Catatonia |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D004565 | Electroconvulsive Therapy |
| ID | Term |
|---|---|
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
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All patients are treated with ECT using different stimulation parameters
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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 | 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 | 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) | 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 | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011580 | Psychological Techniques |