Neurofeedback Training of Anterior Insula Activity Based on Unidimensional vs. Multidimensional Interoceptive Regulation Strategies

February 14, 2026 updated by: Shuxia Yao, University of Electronic Science and Technology of China

A Comparative Study of Anterior Insula Real-time fMRI Neurofeedback Training Based on Unidimensional vs. Multidimensional Interoceptive Regulation Strategies

The purpose of this study is to compare the neural and behavioral effects of real-time functional magnetic resonance imaging (fMRI) neurofeedback training using two different interoceptive strategies: a unidimensional heartbeat detection strategy and a multidimensional interoception strategy. Specifically, the study compares the efficacy of these two regulation strategies in regulating activity of the anterior insula, a key brain region involved in interoceptive and emotional processing.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study uses a randomized between-subject design to compare the efficacy of two interoceptive strategies in regulating anterior insula activity during real-time fMRI neurofeedback training. A total of 60 healthy participants are recruited and are randomly assigned to one of two groups. The heartbeat detection group (HDG; n = 30) uses a heartbeat detection strategy to upregulate anterior insula activity during neurofeedback training. The multidimensional interoception group (MIG; n = 30) uses a multidimensional interoception strategy which involves shifting attention among respiratory sensations, cardiac signals, gastric sensations, and bladder distension, to increase anterior insula activity during neurofeedback training. The neurofeedback protocol includes 4 training sessions with real-time neurofeedback and 1 transfer session without neurofeedback. Each session comprises 6 regulation (upregulate anterior insula activity with interoception strategies) blocks and 6 baseline (rest) blocks. Interoceptive accuracy is assessed using a heartbeat detection task performed before and after neurofeedback training. During MRI scanning, a heartbeat counting task will be employed prior to neurofeedback training to localize the anterior insula. The behavioral effects of neurofeedback training are evaluated using a pain empathy rating task and an interoception/relaxation rating task following the regulation or baseline block. Individual differences in personality traits and interoceptive characteristics are assessed using validated Chinese questionnaires, including State-Trait Anxiety Inventory (STAI), Beck Depression Inventory-Ⅱ (BDI-Ⅱ), Toronto Alexithymia Scale (TAS), Autism Spectrum Quotient (ASQ), Bermond-Vorst Alexithymia Questionnaire (BVAQ), Multidimensional Assessment of Interoceptive Awareness (MAIA), Interoceptive Confusion Questionnaire (ICQ), Interpersonal Reactivity Index (IRI), and Cognitive Flexibility Inventory (CFI). Affective moods are assessed using the Positive and Negative Affect Schedule (PANAS).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 611731
        • University of Electronic Science and Technology of China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • No past or current psychiatric or neurological or other main disorders.

Exclusion Criteria:

  • Current use of medications.
  • History of brain injury Medical or mental illness
  • Contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multidimensional interoception strategy with real-time fMRI neurofeedback
Subjects in the multidimensional interoception group are instructed to regulate anterior insula activity based on visual neurofeedback using a multidimensional interoception strategy that engages four distinct, interrelated interoceptive signals: respiratory signals, heartbeat, gastric sensations, and bladder distension.
Device: real-time fMRI neurofeedback training
Real-time neurofeedback information is computed using the Turbo Brain voyager (TBV) 4.0 software (Brain Innovation, Maastricht, The Netherlands). Functional images are collected and processed in real time based on contrasts of regulation vs. rest conditions. The blood oxygen level dependent (BOLD) signal of the target region is then transformed into visual bars and displayed to participants via the projector screen. Both groups will undergo the same paradigm, but with different interoception strategies.
Other Names:
  • rt-fMRI NF training
Active Comparator: Heartbeat detection strategy with real-time fMRI neurofeedback
Subjects in the heartbeat detection group are instructed to regulate anterior insula activity based on visual neurofeedback by using a heartbeat detection strategy.
Device: real-time fMRI neurofeedback training
Real-time neurofeedback information is computed using the Turbo Brain voyager (TBV) 4.0 software (Brain Innovation, Maastricht, The Netherlands). Functional images are collected and processed in real time based on contrasts of regulation vs. rest conditions. The blood oxygen level dependent (BOLD) signal of the target region is then transformed into visual bars and displayed to participants via the projector screen. Both groups will undergo the same paradigm, but with different interoception strategies.
Other Names:
  • rt-fMRI NF training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal
Time Frame: 1 hour
The anterior insula activity induced during the regulation block compared to the baseline block.
1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interoceptive accuracy
Time Frame: 10 minutes
1/N Σ(1-(|actual heartbeats--reported heartbeats|) / actual heartbeats). N indicates the number of recording blocks.
10 minutes
Pain empathy ratings scores
Time Frame: 1 hour
Subjects are 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) after each regulation/baseline block.
1 hour
Confidence rating scores of interoceptive sensitivity
Time Frame: 10 minutes
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)
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Electronic Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UESTC-neuSCAN-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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