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Clinical Trials/NCT05260749
NCT05260749
Completed
Not Applicable

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

University of Electronic Science and Technology of China1 site in 1 country99 target enrollmentJune 16, 2021
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Electronic Science and Technology of China
Enrollment
99
Locations
1
Primary Endpoint
Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 16, 2021
End Date
December 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Electronic Science and Technology of China
Responsible Party
Principal Investigator
Principal Investigator

Shuxia Yao

Associate Professor

University of Electronic Science and Technology of China

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • History of brain injury Medical or mental illness

Outcomes

Primary Outcomes

Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal

Time Frame: 1 hour

The anterior insula activity induced by neurofeedback training relative to sham feedback training

Secondary Outcomes

  • Confidence rating scores of interoceptive sensitivity(1 hour)
  • pain empathy ratings scores(1 hour)

Study Sites (1)

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