HealthyNCT07416370
Neurofeedback Training of Anterior Insula Activity Based on Unidimensional vs. Multidimensional Interoceptive Regulation Strategies
A study testing real-time fMRI neurofeedback training in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- real-time fMRI neurofeedback training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to 18 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No past or current psychiatric or neurological or other main disorders.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy
- Being tested
- real-time fMRI neurofeedback training
- Keywords
- real-time neurofeedback, anterior insula, interoceptive strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time fMRI neurofeedback trainingDevice
Also called rt-fMRI NF 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.
| Study group | Role | What they receive |
|---|---|---|
| Multidimensional interoception strategy with real-time fMRI neurofeedback | Experimental | 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. Receives: Device: real-time fMRI neurofeedback training |
| Heartbeat detection strategy with real-time fMRI neurofeedback | Active comparator | Subjects in the heartbeat detection group are instructed to regulate anterior insula activity based on visual neurofeedback by using a heartbeat detection strategy. Receives: Device: real-time fMRI neurofeedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal
The anterior insula activity induced during the regulation block compared to the baseline block.
Measured: 1 hour
Secondary outcomes (3)
Pain empathy ratings scores
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.
Measured: 1 hour
Confidence rating scores of interoceptive sensitivity
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)
Measured: 10 minutes
Interoceptive accuracy
1/N Σ(1-(|actual heartbeats--reported heartbeats|) / actual heartbeats). N indicates the number of recording blocks.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start2 Feb 2026
- Primary completion16 May 2026 (estimated)
- Study completion18 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuxia Yao, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416370
- Sponsor's protocol ID
- UESTC-neuSCAN-103
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Anterior Insula Real-time fMRI Neurofeedback Training Based on Unidimensional vs. Multidimensional Interoceptive Regulation Strategies
- ClinicalTrials.gov ID
- NCT07416370
- Acronym / sponsor ID
- UESTC-neuSCAN-103
- Conditions
- Healthy
- Keywords
- real-time neurofeedback, anterior insula, interoceptive strategy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 16 May 2026 (estimated)
- Study completion
- 18 May 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidimensional interoception strategy with real-time fMRI neurofeedback | Experimental | Device: real-time fMRI neurofeedback trainingSubjects 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. |
| Heartbeat detection strategy with real-time fMRI neurofeedback | Active comparator | Device: real-time fMRI neurofeedback trainingSubjects in the heartbeat detection group are instructed to regulate anterior insula activity based on visual neurofeedback by using a heartbeat detection strategy. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No past or current psychiatric or neurological or other main disorders.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real-time fMRI neurofeedback trainingAlso: rt-fMRI NF trainingReal-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. | Device | Heartbeat detection strategy with real-time fMRI neurofeedback, Multidimensional interoception strategy with real-time fMRI neurofeedback |
Primary outcome
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.
3 secondary outcomes
Pain empathy ratings scores
Time frame: 1 hour
Confidence rating scores of interoceptive sensitivity
Time frame: 10 minutes
Interoceptive accuracy
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real-time fMRI neurofeedback training in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.