Real-time fMRI Neurofeedback Training on the Anterior Insula Based on Interoceptive Processing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Procedure: real-time fMRI neurofeedback training procedure
* Procedure: real-time fMRI sham-controlled neurofeedback training procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects without any past or present psychiatric or neurological disorders Exclusion Criteria: History of brain injury Medical or mental illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurofeedback training<br>Subjects in the neurofeedback training group are instructed to regulate their anterior insula activity based on the visual neurofeedback. | Procedure: real-time fMRI neurofeedback training procedure<br>* real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 3.2 software (Brain Innovation, Maastricht, The Netherlands)<br>|
| Sham Comparator: Sham control1<br>Subjects in the sham control group receive the same instruction but perform the regulation based on neurofeedback from a whole slice of top brain (a controlled sham region). | Procedure: real-time fMRI sham-controlled neurofeedback training procedure<br>* real-time fMRI sham neurofeedback training procedure running on the Turbo Brain voyager (TBV) 3.2 software (Brain Innovation, Maastricht, The Netherlands)<br>|
| Sham Comparator: Sham control2<br>Subjects in the sham control group receive the same instruction but perform the regulation based on neurofeedback from the middle temporal gyrus (a controlled sham region). | Procedure: real-time fMRI sham-controlled neurofeedback training procedure<br>* real-time fMRI sham neurofeedback training procedure running on the Turbo Brain voyager (TBV) 3.2 software (Brain Innovation, Maastricht, The Netherlands)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal | The anterior insula activity induced by neurofeedback training relative to sham feedback training | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confidence rating scores of interoceptive sensitivity | Subjects are asked to rate to what extent they can feel their heartbeat based on a Likert Scale ranging from 1-9 (1 = very low and 9 = very high) | 1 hour | 
| pain empathy ratings scores | Subjects were required to rate their empathic feeling towards painful pictures on a Likert Scale ranging from 1-9 (1 = not at all and 9 = very painful) before and after neurofeedback training. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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real-time neurofeedback, anterior insula, Interoceptive Processing