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临床试验/NCT07416370
NCT07416370Enrolling By Invitation不适用

A Comparative Study of Anterior Insula Real-time fMRI Neurofeedback Training Based on Unidimensional vs. Multidimensional Interoceptive Regulation Strategies

University of Electronic Science and Technology of China1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
60
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 purpose of this study is to compare the neural and behavioral effects of real-time functional magnetic resonance imaging (fMRI) neurofeedback training using two different interoceptive strategies: a unidimensional heartbeat detection strategy and a multidimensional interoception strategy. Specifically, the study compares the efficacy of these two regulation strategies in regulating activity of the anterior insula, a key brain region involved in interoceptive and emotional processing.

详细描述

This study uses a randomized between-subject design to compare the efficacy of two interoceptive strategies in regulating anterior insula activity during real-time fMRI neurofeedback training. A total of 60 healthy participants are recruited and are randomly assigned to one of two groups. The heartbeat detection group (HDG; n = 30) uses a heartbeat detection strategy to upregulate anterior insula activity during neurofeedback training. The multidimensional interoception group (MIG; n = 30) uses a multidimensional interoception strategy which involves shifting attention among respiratory sensations, cardiac signals, gastric sensations, and bladder distension, to increase anterior insula activity during neurofeedback training. The neurofeedback protocol includes 4 training sessions with real-time neurofeedback and 1 transfer session without neurofeedback. Each session comprises 6 regulation (upregulate anterior insula activity with interoception strategies) blocks and 6 baseline (rest) blocks. Interoceptive accuracy is assessed using a heartbeat detection task performed before and after neurofeedback training. During MRI scanning, a heartbeat counting task will be employed prior to neurofeedback training to localize the anterior insula. The behavioral effects of neurofeedback training are evaluated using a pain empathy rating task and an interoception/relaxation rating task following the regulation or baseline block. Individual differences in personality traits and interoceptive characteristics are assessed using validated Chinese questionnaires, including State-Trait Anxiety Inventory (STAI), Beck Depression Inventory-Ⅱ (BDI-Ⅱ), Toronto Alexithymia Scale (TAS), Autism Spectrum Quotient (ASQ), Bermond-Vorst Alexithymia Questionnaire (BVAQ), Multidimensional Assessment of Interoceptive Awareness (MAIA), Interoceptive Confusion Questionnaire (ICQ), Interpersonal Reactivity Index (IRI), and Cognitive Flexibility Inventory (CFI). Affective moods are assessed using the Positive and Negative Affect Schedule (PANAS).

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
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • No past or current psychiatric or neurological or other main disorders.

排除标准

  • Current use of medications.
  • History of brain injury Medical or mental illness
  • Contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning).

研究组 & 干预措施

Multidimensional interoception strategy with real-time fMRI neurofeedback

Experimental

Subjects in the multidimensional interoception group are instructed to regulate anterior insula activity based on visual neurofeedback using a multidimensional interoception strategy that engages four distinct, interrelated interoceptive signals: respiratory signals, heartbeat, gastric sensations, and bladder distension.

干预措施: real-time fMRI neurofeedback training (Device)

Heartbeat detection strategy with real-time fMRI neurofeedback

Active Comparator

Subjects in the heartbeat detection group are instructed to regulate anterior insula activity based on visual neurofeedback by using a heartbeat detection strategy.

干预措施: real-time fMRI neurofeedback training (Device)

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 during the regulation block compared to the baseline block.

次要结局

  • Pain empathy ratings scores(1 hour)
  • Confidence rating scores of interoceptive sensitivity(10 minutes)
  • Interoceptive accuracy(10 minutes)

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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