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

U

University of Electronic Science and Technology of China

Status

Completed

Conditions

Healthy

Treatments

Procedure: real-time fMRI sham-controlled neurofeedback training procedure
Procedure: real-time fMRI neurofeedback training procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT05260749
UESTC-neuSCAN-85

Details and patient eligibility

About

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.

Full 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.

Enrollment

99 patients

Sex

All

Ages

18 to 28 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • History of brain injury Medical or mental illness

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

99 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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