NCT06461260招募中不适用
Safety, Efficacy and Neuroimaging Mechanisms of Amygdala Temporal Interference Stimulation Therapy for Depression
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HAMD-17
研究概览
简要总结
The study utilizes a non-invasive deep brain stimulation (temporal interference, TI) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of MRI-compatible TI technology in regulating the amygdala in depressive disorders, providing a more comprehensive basis for the application of TI technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be aged between 18 and 65, with no gender restrictions;
- •A diagnosis of depression made by the study physician based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- •HAMD-17 score of 17 or higher;
- •Participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment;
- •Eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol, and provide their signature on the informed consent form.
排除标准
- •Eligible participants must not have a history of psychiatric or neurological disorders, as judged by the investigator, which may impact the evaluation of the study's efficacy;
- •Participants must not have a history of seizures or prior episodes of epilepsy;
- •The presence of metallic foreign objects within the cranial structure or metallic cardiac implants;
- •Participants must not have a diagnosis of organic brain disease, nor a history of significant cranial trauma or neurosurgical intervention;
- •Participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy);
- •The researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior;
- •Pregnant or breastfeeding;
- •Participants who are concurrently engaged in other clinical interventional trials;
- •Participants presenting with other circumstances that the investigator deems unsuitable for the intervention being studied
结局指标
主要结局
HAMD-17
时间窗: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
次要结局
- SHAPS(Baseline, 4 weeks and 8 weeks)
- SF-36(Baseline and 8 weeks)
- WHOQOL-BREF(Baseline and 8 weeks)
- PSQI(Baseline, 4 weeks and 8 weeks)
- GAD-7(Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks)
- MADRS(Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks)
- Blood sample(Baseline, 4 weeks)
- HAMA(Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks)
- THINC-it®(Baseline, treatment completion day and 8 weeks)
- QIDS-SR(Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks)
研究者
Jingjing Huang, MD
Chief Physician
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
研究点 (1)
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