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

• Sponsor: University of Electronic Science and Technology of China (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05260749
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.9
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Procedure: real-time fMRI neurofeedback training procedure; Procedure: real-time fMRI sham-controlled neurofeedback training procedure	N/A

Detailed Description

A double-blinded, placebo-controled, between-subject design is employed in this study. In a randomized order, a total of 70 healthy subjects will be recruited and assigned into the experimental group (EG), which receives real feedback from the left anterior insula, or the control group (CG) which receives sham feedback from a whole slice of top brain. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Real-time fMRI Neurofeedback Training on the Anterior Insula Via Interoceptive Processing and Its Behavioral Effects
• Actual Study Start Date: Jun 16, 2021
• Anticipated Primary Completion Date: Mar 5, 2022
• Anticipated Study Completion Date: May 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neurofeedback training 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; real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 3.2 software (Brain Innovation, Maastricht, The Netherlands)
Sham Comparator: Sham control 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; real-time fMRI sham neurofeedback training procedure running on the Turbo Brain voyager (TBV) 3.2 software (Brain Innovation, Maastricht, The Netherlands)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 28 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• History of brain injury Medical or mental illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Electronic Science and Technology of China(UESTC)	Chengdu	Sichuan	China

Sponsors and Collaborators

• University of Electronic Science and Technology of China

Investigators

• Principal Investigator: Yao Shuxia, Dr, University of Electronic Science and Technology of China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shuxia Yao, Associate Professor, University of Electronic Science and Technology of China
• ClinicalTrials.gov Identifier: NCT05260749
• Other Study ID Numbers: UESTC-neuSCAN-85
• First Posted: Mar 2, 2022
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shuxia Yao, Associate Professor, University of Electronic Science and Technology of China: real-time neurofeedback; anterior insula; Interoceptive Processing

Study Results

No Results Posted as of Mar 2, 2022