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临床试验/NCT05260749
NCT05260749已完成不适用

Real-time fMRI Neurofeedback Training on the Anterior Insula Via Interoceptive Processing and Its Behavioral Effects

University of Electronic Science and Technology of China1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2021年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
99
试验地点
1
主要终点
Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal

研究概览

简要总结

The main aim of the study is to investigate whether subjects can learn self control of activity of the anterior insula via real-time functional magnetic resonance imaging (fMRI) neurofeedback training based on a regulation strategy of interoceptive processing.

详细描述

A double-blinded, placebo-controled, between-subject design is employed in this study. In a randomized order, a total of 90 healthy subjects will be recruited and assigned into the experimental group (EG; N=33), which receives real feedback from the left anterior insula, or the control group (CG; N=33) which receives sham feedback from a whole slice of top brain, or the control group 2 (CG2; N=33) wich receives sham feedback from the middle temporal gyrus. Neurofeedback training consists of 4 training sessions with real-time feedback and 1 transfer session without feedback. A heartbeat detection task pre- and post-training was used to determine interoceptive accuracy changes induced by neurofeedback training. A pre-training empathy task before training was used to localise the anterior insula and as a baseline of empathic response. A post-training empathy task was used to determine the effects of neurofeedback training on empathic response by comparing with the pre-training one. Behavioral and fMRI data are collected during the empathy tasks and the neurofeedback task. Personality traits of subjects are assessed using validated Chinese version questionnaires, including the Toronto Alexithymia Scale (TAS), Multidimensional Assessment of Interoceptive Awareness (MAIA), Interoceptive Confusion Questionnaire (ICQ), Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Empathy Quotient (EQ). Subjects are asked to complete Positive and Negative Affect Schedule (PANAS) twice before and after the neurofeedback training task.

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)

入排标准

年龄范围
18 Years 至 28 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects without any past or present psychiatric or neurological disorders

排除标准

  • History of brain injury Medical or mental illness

结局指标

主要结局

Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal

时间窗: 1 hour

The anterior insula activity induced by neurofeedback training relative to sham feedback training

次要结局

  • Confidence rating scores of interoceptive sensitivity(1 hour)
  • pain empathy ratings scores(1 hour)

研究者

发起方
University of Electronic Science and Technology of China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shuxia Yao

Associate Professor

University of Electronic Science and Technology of China

研究点 (1)

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