Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Blood oxygenation level dependent signal of the target brain region of interest
研究概览
简要总结
The purpose of this study is to determine the potential efficacy of real-time functional magnetic resonance imaging neurofeedback (RT- functional magnetic resonance imaging (fMRI) -NF) in regulating brain activity and psychophysiological functions.
详细描述
The overall goal of the outlined study is to establish a real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) protocol aiming at modulating brain activity and psychophysiological functions. About two weeks after the initial training session it will be estimated how stable training effects have been. The two weeks in between, subjects will receive ambulatory training of the strategies via a smartphone-based application.
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
- •Access to smartphone
- •Availability to participate in the study
排除标准
- •Color blindness
- •Presence of cardiovascular disease
- •Medication intake affecting cardiovascular function
- •Medical MRI contraindication
研究组 & 干预措施
Contingent
Contingent RT-fMRI-NF of brain activity in the target region of interest
干预措施: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) (Other)
Contingent
Contingent RT-fMRI-NF of brain activity in the target region of interest
干预措施: Ambulatory Training (Behavioral)
Non-contingent
Sham RT-fMRI-NF of brain activity of previously recorded subject
干预措施: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) (Other)
Non-contingent
Sham RT-fMRI-NF of brain activity of previously recorded subject
干预措施: Ambulatory Training (Behavioral)
结局指标
主要结局
Blood oxygenation level dependent signal of the target brain region of interest
时间窗: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity
Blood pressure
时间窗: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
assessed via oscillometry, expressed in mmHg
次要结局
- Feedback on adverse events during the scanner and ambulatory training(study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year))