Research on Optimization Program of Magnetic Seizure Therapy for Bipolar Mania Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- changes in the Young Mania Rating Scale
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 Young Mania Rating Scale (YMRS) score ≥ 10;
- •informed consent in written form.
排除标准
- •primary 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;
- •Unremovable metal implants.
- •other conditions that investigators consider to be inappropriate to participate in this trial.
结局指标
主要结局
changes in the Young Mania Rating Scale
时间窗: At baseline, 4-week follow-up
次要结局
- changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS)(At baseline and 4-week follow-up)
- changes in the Montgomery Åsberg Depression Rating Scale (MADRS)(At baseline and 4-week follow-up)
- changes in the motor threshold (MT)(At baseline and 24 hours after the first treatment)
- changes in the Novel P300(At baseline and 24 hours after the first treatment)
- changes in the resting state network(At baseline, 24 hours after the first treatment, and at 4-week follow-up)
- changes in auditory evoked potentials (AEP)(At baseline and 24 hours after the first treatment)
- changes in the Clinical Global Impression Scale (CGI)(At baseline and 4-week follow-up)
- changes in brain gamma-aminobutyric acid （GABA）levels(At baseline, 24 hours after the first treatment, and at 4-week follow-up)