跳至主要内容
临床试验/NCT02560233
NCT02560233撤回不适用

Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback

University Hospital, Basel, Switzerland0 个研究点目标入组 60 人开始时间: 2020年8月1日最近更新:
适应症
干预措施

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

Experimental

Contingent RT-fMRI-NF

干预措施: Contingent RT-fMRI-NF (Other)

Non-contingent

Sham Comparator

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)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

相似试验