Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- changes in The Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and its safety for bipolar mania. Half of the participants will receive MST, while the other half will receive electroconvulsive therapy (ECT).
详细描述
Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive therapy (ECT).
Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the substantial impedance of the scalp and skull shuts most of the electrical stimulus away from the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area of the brain because they can pass the scalp and skull without resistance. In Addition, electric current will penetrate into deeper structures, while magnetic stimulus are only capable to reach a depth of a few centimeters. As a consequence, MST are able to generate focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the capability to produce comparable therapeutic benefits with the absence of apparent cognitive side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 diagnosis of bipolar I disorder and currently in a manic episode;
- •convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
- •the positive and negative syndrome scale (PANSS) score ≥ 60;
- •informed consent in written form.
排除标准
- •diagnosis of other mental disorders;
- •severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency;
- •present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants;
- •failure to respond to an adequate trial of ECT lifetime;
- •are pregnant or intend to get pregnant during the study;
- •other conditions that investigators consider to be inappropriate to participate in this trial.
结局指标
主要结局
changes in The Positive and Negative Syndrome Scale (PANSS)
时间窗: At baseline, 4-week follow-up, and 8-week follow-up
次要结局
- changes in Novel P300(At baseline and the day after the first treatment)
- changes in MATRICS Consensus Cognitive Battery (MCCB)(At baseline and 4-week follow-up)
- changes in auditory evoked potential (AEP)(At baseline and the day after the first treatment)
- changes in Clinical Global Impressions (CGI)(At baseline and 4-week follow-up)
- changes in motor threshold (MT)(At baseline and the day after the first treatment)
- changes in brain gamma-aminobutyric acid （GABA）levels(At baseline, the day after the first treatment, and at 4-week follow-up)
- changes in resting state network(At baseline, the day after the first treatment, and at 4-week follow-up)