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

NCT ID: NCT05260749

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2022-12-01

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.

Conditions

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Healthy

Keywords

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real-time neurofeedback anterior insula Interoceptive Processing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Neurofeedback training

Subjects in the neurofeedback training group are instructed to regulate their anterior insula activity based on the visual neurofeedback.

Group Type EXPERIMENTAL

real-time fMRI neurofeedback training procedure

Intervention Type PROCEDURE

real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 3.2 software (Brain Innovation, Maastricht, The Netherlands)

Sham control1

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).

Group Type SHAM_COMPARATOR

real-time fMRI sham-controlled neurofeedback training procedure

Intervention Type PROCEDURE

real-time fMRI sham neurofeedback training procedure running on the Turbo Brain voyager (TBV) 3.2 software (Brain Innovation, Maastricht, The Netherlands)

Sham control2

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).

Group Type SHAM_COMPARATOR

real-time fMRI sham-controlled neurofeedback training procedure

Intervention Type PROCEDURE

real-time fMRI sham neurofeedback training procedure running on the Turbo Brain voyager (TBV) 3.2 software (Brain Innovation, Maastricht, The Netherlands)

Interventions

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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)

Intervention Type 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)

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Electronic Science and Technology of China

OTHER

Sponsor Role lead

Responsible Party

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Shuxia Yao

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yao Shuxia, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Electronic Science and Technology of China

Locations

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University of Electronic Science and Technology of China(UESTC)

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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Zhang Y, Zhang Q, Wang J, Zhou M, Qing Y, Zou H, Li J, Yang C, Becker B, Kendrick KM, Yao S. "Listen to your heart": A novel interoceptive strategy for real-time fMRI neurofeedback training of anterior insula activity. Neuroimage. 2023 Dec 15;284:120455. doi: 10.1016/j.neuroimage.2023.120455. Epub 2023 Nov 10.

Reference Type DERIVED
PMID: 37952779 (View on PubMed)

Other Identifiers

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UESTC-neuSCAN-85

Identifier Type: -

Identifier Source: org_study_id