Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events
研究概览
简要总结
Background:
Electroconvulsive therapy (ECT) is used to treat people with severe depression. During ECT, the brain is given electric pulses that cause a seizure. Although it is effective, it can cause side effects, including memory loss. Researchers want to study a new way to give ECT called iLAST.
Objective:
To see if iLAST is safe and feasible in treating depression.
Eligibility:
People ages 22 70 years old who have major depressive disorder and are eligible for ECT
Design:
Participants will be screened under protocol 01-M-0254. This includes:
Medical and psychiatric history and exam
Blood and urine tests
Participants will be inpatients at the Clinical Center. They study has 3 phases and will last up to 20 weeks.
Phase I will last 1 week. It includes:
MRI: Participants will lie in a scanner that takes pictures of the body
MEG: A cone over the participant s head will record brain activity.
TMS: A wire coil placed on the participant s scalp will produce an electrical current to affect brain activity.
SEP: An electrode on the participant s wrist will give a small electrical shock to test nerve function.
Phase II will last 2 and a half weeks. It includes:
Seven sessions of iLAST under general anesthesia. Participants may also get standard ECT.
EEG: A small electrode placed on the participant s scalp will record brain waves.
Interviews about mood, symptoms, and side effects. Participants facial expressions may be video recorded.
TMS
Phase III will last at least 1 week. It will include:
MRI
EEG
TMS
MEG
Standard ECT if needed. Participants will have sessions every other day, 3 times a week.
详细描述
Objective
Despite advances in antidepressant interventions, none has replaced electroconvulsive therapy (ECT) in its acute efficacy and spectrum of action in severely depressed patients, including in psychotic depression, catatonia, and acutely suicidal patients. However, ECT carries a risk of significant adverse effects including cognitive and physiological side effects, some of which can be long term. The side effects are thought to be related to stimulation of brain areas beyond those implicated in depression, so called non-target regions. While these advances have improved the safety and tolerability of seizure therapy, a risk of cognitive side effects remains, and none of the currently used procedures individualize the current amplitude for each patient despite knowledge that anatomical variation significantly impacts the strength of the current delivered to the brain. We propose a first-in-human safety and feasibility study of this approach (termed individualized low amplitude seizure therapy , or iLAST). iLAST introduces three areas of improvement over conventional ECT:
- use of a multi-electrode array to selectively target different regions of the brain coupled
with computational electric field modeling on an individual patient basis to examine the
current flow in the brain. 2. an alternative dosing strategy in which the stimulus is titrated in the current amplitude
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events
时间窗: ongoing
Successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events
次要结局
- Neurocognitive battery known to be sensitive to cognitive effects of ECT, with alternative versions to avoid practice effects; Amplitude-titrated seizure threshold (STa), measured electrical motor threshold (MT), and simulated MT derived from re...(Ongoing)