HealthyNCT07389486
Continuous vs. Intermittent Rt-fMRI Neurofeedback Training of the Anterior Insula
A study testing real-time fMRI neurofeedback training procedure in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The main aim of this study is to compare the efficacy of intermittent with continuous real-time functional magnetic resonance imaging (fMRI) neurofeedback on anterior insula regulation and associated behavioral changes. 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 procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2026to 8 Jun 2027
- 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
- Healthy subjects without any past or present psychiatric or neurological disorders
Who cannot join
- 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, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
Shuxia Yao
About this study
Official title: A Comparative Study of Continuous vs. Intermittent Real-time fMRI Neurofeedback in Regulating Anterior Insula Activity
The main aim of this study is to compare the efficacy of intermittent with continuous real-time functional magnetic resonance imaging (fMRI) neurofeedback on anterior insula regulation and associated behavioral changes.
Read the detailed description
A double-blinded, placebo-controled, between-subject design is employed in this study. A total of 90 healthy subjects will be recruited and randomly assigned into the intermittent experimental group (EG1; N=30), which receives intermittent feedback from the left anterior insula after each block, the control group (CG; N=30) after each block, which receives sham feedback from the middle temporal gyrus (MTG), and the continuous expermiental group (EG2; N=30), which receives real-time feedback from the left anterior insula. Comparisons between the EG1 and the CG are used to validate the efficacy of intermittent neurofeedback and comparisons between the EG2 and the CG are used to determine the better neurofeedback type (intermittent vs. continuous).
The neurofeedback training task consists of 4 training sessions with real-time feedback and 1 transfer session without feedback. Each session comprises 5 regulation blocks and 5 rest blocks. At the end of each block, participants are presented with pain-related images and asked to rate their level of pain empathy, which was used to determine the effects of neurofeedback training on empathic responses. A heartbeat detection task is performed pre- and post-training to measure interoceptive accuracy changes induced by neurofeedback training. A functional localizer task (heartbeat counting task) before training was used to localise the anterior insula. Personality traits of subjects are assessed using validated Chinese version questionnaires, including the Toronto Alexithymia Scale (TAS), Multidimensional Assessment of Interoceptive Awareness (MAIA), Bermond-Vorst Alexithymia Questionnaire (BVAQ),Interoceptive Confusion Questionnaire (ICQ), Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Interpersonal Reactivity Index (IRI), and Cognitive Flexibility Inventory (CFI). Subjects are asked to complete Positive and Negative Affect Schedule (PANAS) twice before and after the neurofeedback training task to measure mood changes.
- Conditions
- Healthy
- Being tested
- real-time fMRI neurofeedback training procedure, real-time fMRI sham-controlled neurofeedback training procedure
- Keywords
- Real-time neurofeedback, Anterior insula, Feedback types, Interoceptive processing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time fMRI neurofeedback training procedureProcedure or surgery
real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)
real-time fMRI sham-controlled neurofeedback training procedureProcedure or surgery
real-time fMRI sham neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)
real-time fMRI neurofeedback training procedureProcedure or surgery
real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)
| Study group | Role | What they receive |
|---|---|---|
| Intermittent neurofeedback training | Experimental | Subjects in the intermittent neurofeedback training group are instructed to regulate their anterior insula activity based on the visual neurofeedback after each regulation block. This intermittent neurofeedback is based on averaged activity of the anterior insula during the regulation block. Receives: Procedure: real-time fMRI neurofeedback training procedure |
| Intermittent sham control | Sham comparator | Subjects in the sham control group receive the same instruction but perform the regulation based on sham neurofeedback from the middle temporal gyrus (a controlled sham region). Receives: Procedure: real-time fMRI sham-controlled neurofeedback training procedure |
| Continuous neurofeedback training | Experimental | Subjects in the continuous neurofeedback training group are instructed to regulate their anterior insula activity based on the real-time visual neurofeedback during regulation blocks. Receives: Procedure: real-time fMRI neurofeedback training procedure |
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
Pain empathy ratings scores
Subjects were 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) before and after neurofeedback training.
Measured: 1 hour
Secondary outcomes (2)
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: 1 hour
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 posted5 Feb 2026
- Study start28 Jan 2026
- Primary completion6 Jun 2026 (estimated)
- Study completion8 Jun 2027 (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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 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
- NCT07389486
- Sponsor's protocol ID
- UESTC-neuSCAN-104
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Continuous vs. Intermittent Real-time fMRI Neurofeedback in Regulating Anterior Insula Activity
- ClinicalTrials.gov ID
- NCT07389486
- Acronym / sponsor ID
- UESTC-neuSCAN-104
- Conditions
- Healthy
- Keywords
- Real-time neurofeedback, Anterior insula, Feedback types, Interoceptive processing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 6 Jun 2026 (estimated)
- Study completion
- 8 Jun 2027 (estimated)
- First posted
- 5 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 main aim of this study is to compare the efficacy of intermittent with continuous real-time functional magnetic resonance imaging (fMRI) neurofeedback on anterior insula regulation and associated behavioral changes.
Detailed description
A double-blinded, placebo-controled, between-subject design is employed in this study. A total of 90 healthy subjects will be recruited and randomly assigned into the intermittent experimental group (EG1; N=30), which receives intermittent feedback from the left anterior insula after each block, the control group (CG; N=30) after each block, which receives sham feedback from the middle temporal gyrus (MTG), and the continuous expermiental group (EG2; N=30), which receives real-time feedback from the left anterior insula. Comparisons between the EG1 and the CG are used to validate the efficacy of intermittent neurofeedback and comparisons between the EG2 and the CG are used to determine the better neurofeedback type (intermittent vs. continuous).
The neurofeedback training task consists of 4 training sessions with real-time feedback and 1 transfer session without feedback. Each session comprises 5 regulation blocks and 5 rest blocks. At the end of each block, participants are presented with pain-related images and asked to rate their level of pain empathy, which was used to determine the effects of neurofeedback training on empathic responses. A heartbeat detection task is performed pre- and post-training to measure interoceptive accuracy changes induced by neurofeedback training. A functional localizer task (heartbeat counting task) before training was used to localise the anterior insula. Personality traits of subjects are assessed using validated Chinese version questionnaires, including the Toronto Alexithymia Scale (TAS), Multidimensional Assessment of Interoceptive Awareness (MAIA), Bermond-Vorst Alexithymia Questionnaire (BVAQ),Interoceptive Confusion Questionnaire (ICQ), Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Interpersonal Reactivity Index (IRI), and Cognitive Flexibility Inventory (CFI). Subjects are asked to complete Positive and Negative Affect Schedule (PANAS) twice before and after the neurofeedback training task to measure mood changes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermittent neurofeedback training | Experimental | Procedure: real-time fMRI neurofeedback training procedureSubjects in the intermittent neurofeedback training group are instructed to regulate their anterior insula activity based on the visual neurofeedback after each regulation block. This intermittent neurofeedback is based on averaged activity of the anterior insula during the regulation block. |
| Intermittent sham control | Sham comparator | Procedure: real-time fMRI sham-controlled neurofeedback training procedureSubjects in the sham control group receive the same instruction but perform the regulation based on sham neurofeedback from the middle temporal gyrus (a controlled sham region). |
| Continuous neurofeedback training | Experimental | Procedure: real-time fMRI neurofeedback training procedureSubjects in the continuous neurofeedback training group are instructed to regulate their anterior insula activity based on the real-time visual neurofeedback during regulation blocks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects without any past or present psychiatric or neurological disorders
Key exclusion criteria (2 listed)
- 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 training procedurereal-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands) | Procedure or surgery | Intermittent neurofeedback training |
| real-time fMRI sham-controlled neurofeedback training procedurereal-time fMRI sham neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands) | Procedure or surgery | Intermittent sham control |
| real-time fMRI neurofeedback training procedurereal-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands) | Procedure or surgery | Continuous neurofeedback training |
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.
Pain empathy ratings scores
Time frame: 1 hour
Subjects were 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) before and after neurofeedback training.
2 secondary outcomes
Confidence rating scores of interoceptive sensitivity
Time frame: 1 hour
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 5 Feb 2026.
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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.
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 procedure 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 2 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: looking for participants now, as of the sponsor's last update on 5 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. Some participants in this study may receive a placebo. 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?
Contact Shuxia Yao, Dr (18111297596, yaoshuxia@uestc.edu.cn), or a site near the patient. 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). The study lists 2 primary outcomes in all. 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 5 Feb 2026.