Real-time Neurofeedback Training of Fronto-limbic Areas Functional Connectivity to Reduce Arousal
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest.
研究概览
简要总结
This is randomized active-sham group controlled between-subject real-time fMRI neurofeedback trial aimed at modulating the ventromedial prefrontal cortex (vmPFC)-amygdala pathway to control subjective anxiety and arousal.
详细描述
The present randomized active-sham group controlled between-subject real-time fMRI neurofeedback trial aims at determining if (1) subjects can gain volitional control over the vmPFC-amygdala pathway involved in implicit emotion regulation and arousal by means of connectivity informed neurofeedback, (2) whether the training has specific effects on the behavioral and psychophysiological arousal level, and (3) or the amygdala or the vmPFC connectivity, respectively.
The present project will determine the efficacy of the modulation of the vmPFC-amygdala functional connectivity pathway using vmPFC-amygdala upregulation (n = 25 subjects) compared to a sham control condition (targeting pathways not involved in emotion regulation, n = 20).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
The recruiter and the person in charge of conducting the experiment will be blind to the experimental condition, as will the participants.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 18 years old
- •other genders
- •No past or current psychiatric or neurological or other main disorders.
排除标准
- •Pregnant, taking oral contraceptives
- •Current use of medications
- •Contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning).
结局指标
主要结局
Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest.
时间窗: 40 minutes
Increased functional connectivity computed from BOLD fMRI over the course of the real-time NF-fMRI training sessions in the neurofeedback group (regions of interest: bilateral amygdala and prefrontal area) but not in the sham group (regions of interest: bilateral motor cortex and primary auditory areas). Functional connectivity strength will be represented by bivariate regression coefficients from a general linear model characterizing the association between their BOLD signal timeseries
次要结局
- Level of behavioural arousal assessed on NRS from 0 to 10(10 minutes)
研究者
Benjamin Becker
Professor
University of Electronic Science and Technology of China