Clinical trial NCT05260749: Real-time fMRI Neurofeedback Training on the Anterior Insula Based on Interoceptive Processing
Official title: Real-time fMRI Neurofeedback Training on the Anterior Insula Via Interoceptive Processing and Its Behavioral Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: real-time neurofeedback
anterior insula
Interoceptive Processing
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal
timeFrame: 1 hour
Secondary outcomes:
measure: Confidence rating scores of interoceptive sensitivity
timeFrame: 1 hour
measure: pain empathy ratings scores
timeFrame: 1 hour
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China(UESTC)
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Yao Shuxia, Dr
role: PRINCIPAL_INVESTIGATOR
References: