Temporal Interference Stimulation of Amygdala and dLPFC: A Randomized Controlled Trial for Adolescent Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- GAD-7
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 adolescent depressive disorders.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be aged between 14 and 18, 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
GAD-7
时间窗: Baseline, after treatment, 1 week, 4 weeks and 8 weeks
ARI
时间窗: Baseline and 8 weeks
MADRS
时间窗: Baseline, after treatment, 1 week, 4 weeks and 8 weeks
PHQ-A
时间窗: Baseline, after treatment, 1 week, 4 weeks and 8 weeks
SF-36
时间窗: Baseline and 8 weeks
SHAPS
时间窗: Baseline, 4 weeks and 8 weeks
PSQI
时间窗: Baseline, 4 weeks and 8 weeks
WHOQOL-BREF
时间窗: Baseline and 8 weeks
HAMD-17
时间窗: Baseline, after treatment, 1 week, 4 weeks and 8 weeks
HAMA
时间窗: Baseline, after treatment, 1 week, 4 weeks and 8 weeks
OSI
时间窗: Baseline, 4 weeks and 8 weeks
For use when the patient exhibits self-harming behavior
次要结局
未报告次要终点
研究者
huangjingjing
Chief Physician
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University