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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Procedure: real-time fMRI sham-controlled neurofeedback training procedure; Procedure: real-time fMRI neurofeedback training procedure

• Registration Number: NCT05260749
• Lead Sponsor: University of Electronic Science and Technology of China

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-06-16
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-03-02
• Primary Completion: 2022-11-15
• Status Verified: 2022-12
• Study Completion: 2022-12-01
• Last Update Submitted: 2022-12-11
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

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

Exclusion Criteria

• History of brain injury Medical or mental illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham control1	real-time fMRI sham-controlled neurofeedback training procedure	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).
Sham control2	real-time fMRI sham-controlled neurofeedback training procedure	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).
Neurofeedback training	real-time fMRI neurofeedback training procedure	Subjects in the neurofeedback training group are instructed to regulate their anterior insula activity based on the visual neurofeedback.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Confidence rating scores of interoceptive sensitivity	1 hour	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)
pain empathy ratings scores	1 hour	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.

Trial Locations

Locations (1)

University of Electronic Science and Technology of China(UESTC); 🇨🇳 Chengdu, Sichuan, China