Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 60
- 主要终点
- Hypothalamic-pituitary-adrenal (HPA) axis reactivity
研究概览
简要总结
The overall goal of the outlined study is to establish a Real-Time (RT) functional Magnetic Resonance Imaging (fMRI) Neurofeedback (NF) (RT-fMRI-NF) protocol aiming at modulating neural, endocrine, and subjective reactivity to psychosocial stress.
详细描述
The overall goal of the outlined study is to establish an RT-fMRI-NF protocol aiming at modulating neural, endocrine, and subjective reactivity to psychosocial stress. More specifically, the investigators pursue the following goals: a) to evaluate whether neural and subjective stress-reactivity can be modified by training volitional control over targeted brain activity by means of RT-fMRI-NF; b) to evaluate whether neuromodulation by means of RT-fMRI-NF can be used as a new way to modulate hormone-release into the periphery; and c) to evaluate whether the efficacy of neuromodulation by RT-fMRI-NF can also be reflected on EEG data as well as the autonomic nervous system (ANS) measured by heart rate variability (HRV).
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sufficient spoken and written knowledge of English
- •Right-handedness
- •Ability to participate in study procedures
排除标准
- •Present or past psychological or psychiatric therapy
- •Major or unstable general medical conditions
- •Presence of cardiovascular disease
- •Current intake of any medication interfering hormonal assessments
- •History of major cerebral injury
- •Medical MRI contraindication
研究组 & 干预措施
Contingent
Contingent RT-fMRI-NF
干预措施: Contingent RT-fMRI-NF (Other)
Non-contingent
Sham RT-fMRI-NF
干预措施: Sham RT-fMRI-NF (Other)
结局指标
主要结局
Hypothalamic-pituitary-adrenal (HPA) axis reactivity
时间窗: At study day one
Assessed via salivary cortisol
Blood oxygenation level dependent signal of the target brain region of interest
时间窗: At study day one
Blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity
次要结局
- Psychophysiological stress reactivity - heart rate variability(At study day one)
- Psychophysiological stress reactivity - blood pressure(At study day one)
- Subjective stress reactivity(At study day one)
- Electrical activity of the brain(At study day one)
- Psychophysiological stress reactivity - heart rate(At study day one)
