Optimizing Stimulation Parameters for Electroconvulsive Therapy (PRESTO)
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Zachary Rosenthal, MD PhD
- 电话号码：19738976511
- 邮箱：Zachary.Rosenthal@pennmedicine.upenn.edu
研究联系人备份
- 姓名：Mario Cristancho, MD
- 邮箱：marioc@pennmedicine.upenn.edu
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19146
- Pennsylvania Hospital
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接触：
- Zachary Rosenthal
- 电话号码：9738976511
- 邮箱：Zachary.Rosenthal@pennmedicine.upenn.edu
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-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Index: Standard titration table
Patients are treated with ECT using titration table 1 (alternating increases in frequency and duration)
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Electrical stimulation under anesthesia
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实验性的：Index: Frequency-then-duration
ECT provided using Table 2, frequency uptitration followed by duration uptitration
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Electrical stimulation under anesthesia
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实验性的：Index: Duration then Frequency
ECT provided using Table 3, duration titration then frequency titration
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Electrical stimulation under anesthesia
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其他：Maintenance
Internal cross-over arm in which patients undergo 8 sessions using 8 randomized sub-convulsive stimulation protocols
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Electrical stimulation under anesthesia
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Brain hemodynamics
大体时间：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.
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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.
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Electroencephalography - Seizure Duration
大体时间：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.
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Bilateral EEG over FP1 and FP2 zones, from which we will compute seizure duration (in seconds)
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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.
|
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Electroencephalography - theta band power
大体时间：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.
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Bilateral EEG over FP1 and FP2 zones, from which we will compute theta band power (in dB)
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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.
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Electroencephalography - Brain Symmetry Index
大体时间：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.
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Bilateral EEG over FP1 and FP2 zones, from which we will compute brain symmetry index (unitless)
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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.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quick Inventory of Depression Self-Report
大体时间：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.
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Depression symptom scale filled out by patient.
Unitless, ranging from 0-27.
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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.
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Bush Francis Catatonia Rating Scale
大体时间：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.
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Catatonia rating scale conducted by clinical team.
Unitless, ranging from 0-69.
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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.
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Single Letter Fluency
大体时间：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.
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Test of verbal fluency.
Unit is number of words starting with a given letter provided in a one minute period.
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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.
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3 word registration and recall
大体时间：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.
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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.
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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.
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Psychotic Depression Assessment Scale (PDAS)
大体时间：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
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Psychosis rating scale for patients with psychosis, to be administered by clinical team.
Unitless, ranging from 0-44.
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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
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Clinical Global Impressions Scale for Severity and Improvement
大体时间：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.
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To be determined by clinical team.
Unitless, ranging from 0-7.
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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.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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