试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- actual neural activation in brain
研究概览
简要总结
Electrical vagus nerve stimulation (VNS) was approved by FDA for treatment of chronic recurrent depression in 2005. Recently, non-invasive, transcutaneous auricular vagus nerve stimulation （taVNS） has already been used for depression treatment. However, the neural mechanism remains unclear, and the relationship between stimulation parameters and neural response were also unknown. The present study aims to investigate the specific brain activation in depression patients after taVNS，compared with healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets ICD-10 diagnosis standard;
- •without taking anti-depressive medication or other psychiatric medications 2 weeks before the experiment;
- •Patient has exhibited symptoms for at least 2 months, but no longer than 2 years.
排除标准
- •With current addiction to drugs;
- •With other severe organic diseases, such as severe heart disease, kidney failure etc;
- •disagree with the consent form.
- •Cannot receive MRI scan.
研究组 & 干预措施
Active-raVNS
Transcutaneous electrical vagus nerve stimulation at ear.
干预措施: Transcutaneous electrical vagus nerve stimulation (Device)
Sham-raVNS
Sham vagus nerve stimulation at ear.
干预措施: Sham vagus nerve stimulation (Device)
结局指标
主要结局
actual neural activation in brain
时间窗: 2 hours
By using fMRI technology, the BOLD signal of brain is analyzed.
次要结局
- Heart rate variability(2 hours)