- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07416370
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
Enrolling by invitation
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
60
Phase
- 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
-
-
Sichuan
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Chengdu, Sichuan, China, 611731
- University of Electronic Science and Technology of China
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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:
|
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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.
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)
February 2, 2026
Primary Completion (Estimated)
May 16, 2026
Study Completion (Estimated)
May 18, 2026
Study Registration Dates
First Submitted
January 28, 2026
First Submitted That Met QC Criteria
February 14, 2026
First Posted (Actual)
February 18, 2026
Study Record Updates
Last Update Posted (Actual)
February 18, 2026
Last Update Submitted That Met QC Criteria
February 14, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID 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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