HealthyNCT07211269
Individual Differences in Cognitive Control Predict Real-time fMRI Neurofeedback Performance
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 goal of this study is to investgate whether individual differences of cognitive control capacity could predict neurofeedback performance and the behavioral effects resulting from successful anterior insula regulation via interoceptive strategy. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Real-time fMRI neurofeedback training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2025to 12 Jan 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 35 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 and color blindness or weakness.
- The presence of metal in the body or claustrophobia.
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, Chengdu, 611731
Shuxia Yao, 18111297596, yaoshuxia@uestc.edu.cn
About this study
The goal of this study is to investgate whether individual differences of cognitive control capacity could predict neurofeedback performance and the behavioral effects resulting from successful anterior insula regulation via interoceptive strategy.
Read the detailed description
The experimental protocol comprises two visits with a 3-7 days interval. The first visit includes: (1) completion of standardized psychological questionnaires, (2) pre-test of the heartbeat counting task (HCT), and (3) four validated cognitive control tasks, including the Go/No-Go task, Stroop task, Task-switching task, N-back task. The main task of the second visit is a fMRI task followed by a post-test of the HCT. The MRI scanning protocol includes anatomical scan, two resting-state scans (pre- and post-training), four runs of fMRI neurofeedback training and a transfer run without feedback. During the regulation block of the training task, participants are asked to upregulate the anterior insula activity followed by a pain empathy rating and strategy efficacy rating. All participants receive real-time neurofeedback from the left anterior insula. Scores of questionnaires including Positive and Negative Affect Schedule, Beck Depression Inventory-Ⅱ, Autism Spectrum Quotient, State-Trait Anxiety Inventory, Interpersonal Reactivity Index, Toronto Alexithymia scale, Bermond-Vorst Alexithymia Questionnaire, Interoceptive Confusion Questionnaire, Multidimensional Assessment of Interoceptive Awareness, Cognitive Flexibility Inventory are also collected before the experiment.
- Conditions
- Healthy
- Being tested
- Real-time fMRI neurofeedback training
- Keywords
- Neurofeedback Performance, Interoception, Cognitive Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time fMRI neurofeedback trainingOther
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 BOLD signal of the target region is then transformed into visual bars and displayed to participants via the projector screen while participants keep using regulation strategy (heartbeat interoception in our study) to upregulate the target region.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback group | Experimental | Participants received real-time neurofeedback information from the target regulation brain region. Receives: Other: Real-time fMRI neurofeedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD signal of the anterior insula during neurofeedback training
The anterior insula activity induced by regulation relative to rest blocks in the neurofeedback training task and transfer task.
Measured: 1 hour
Behavioral measurements in the cognitive control tasks
Response time and accuracy are recorded in the cognitive control tasks (i.e., the Go/No-Go task, Stroop task, Task-switching, N-back task).
Measured: 1 hour
Secondary outcomes (4)
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) after each block.
Measured: 1 hour
Strategy efficacy rating scores
Subjects were required to rate the strategy efficacy on a Likert Scale ranging from 1-9 (1 = not at all and 9 = very) after each block.
Measured: 1 hour
Intero-ceptive accuracy
The ratio of participants' perceived number of heartbeat relative to the recorded number of heartbeat in the heartbeat counting task.
Measured: 15 minutes
Confidence rating scores of interoceptive sensitivity
Subjects were 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) in the heartbeat counting task.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start3 Sep 2025
- Primary completion27 Dec 2025 (estimated)
- Study completion12 Jan 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- Investigators
- Yao Shuxia, Dr., Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211269
- Sponsor's protocol ID
- UESTC-neuSCAN-95
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Differences in Cognitive Control Predict Real-time fMRI Neurofeedback Performance
- ClinicalTrials.gov ID
- NCT07211269
- Acronym / sponsor ID
- UESTC-neuSCAN-95
- Conditions
- Healthy
- Keywords
- Neurofeedback Performance, Interoception, Cognitive Control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 27 Dec 2025 (estimated)
- Study completion
- 12 Jan 2026 (estimated)
- First posted
- 7 Oct 2025 (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 goal of this study is to investgate whether individual differences of cognitive control capacity could predict neurofeedback performance and the behavioral effects resulting from successful anterior insula regulation via interoceptive strategy.
Detailed description
The experimental protocol comprises two visits with a 3-7 days interval. The first visit includes: (1) completion of standardized psychological questionnaires, (2) pre-test of the heartbeat counting task (HCT), and (3) four validated cognitive control tasks, including the Go/No-Go task, Stroop task, Task-switching task, N-back task. The main task of the second visit is a fMRI task followed by a post-test of the HCT. The MRI scanning protocol includes anatomical scan, two resting-state scans (pre- and post-training), four runs of fMRI neurofeedback training and a transfer run without feedback. During the regulation block of the training task, participants are asked to upregulate the anterior insula activity followed by a pain empathy rating and strategy efficacy rating. All participants receive real-time neurofeedback from the left anterior insula. Scores of questionnaires including Positive and Negative Affect Schedule, Beck Depression Inventory-Ⅱ, Autism Spectrum Quotient, State-Trait Anxiety Inventory, Interpersonal Reactivity Index, Toronto Alexithymia scale, Bermond-Vorst Alexithymia Questionnaire, Interoceptive Confusion Questionnaire, Multidimensional Assessment of Interoceptive Awareness, Cognitive Flexibility Inventory are also collected before the experiment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback group | Experimental | Other: Real-time fMRI neurofeedback trainingParticipants received real-time neurofeedback information from the target regulation brain region. |
Who may qualify
- Ages
- 18 to 35 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 and color blindness or weakness.
- The presence of metal in the body or claustrophobia.
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 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 BOLD signal of the target region is then transformed into visual bars and displayed to participants via the projector screen while participants keep using regulation strategy (heartbeat interoception in our study) to upregulate the target region. | Other | Neurofeedback group |
Primary outcome
BOLD signal of the anterior insula during neurofeedback training
Time frame: 1 hour
The anterior insula activity induced by regulation relative to rest blocks in the neurofeedback training task and transfer task.
Behavioral measurements in the cognitive control tasks
Time frame: 1 hour
Response time and accuracy are recorded in the cognitive control tasks (i.e., the Go/No-Go task, Stroop task, Task-switching, N-back task).
4 secondary outcomes
Pain empathy ratings scores
Time frame: 1 hour
Strategy efficacy rating scores
Time frame: 1 hour
Intero-ceptive accuracy
Time frame: 15 minutes
Confidence rating scores of interoceptive sensitivity
Time frame: 15 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 7 Oct 2025.
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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.
Yao Shuxia, Dr. principal investigator
University of Electronic Science and Technology of China
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 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 7 Oct 2025. 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?
Contact Keith M Kendrick, Dr. (86-28-61830811, k.kendrick.uestc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD signal of the anterior insula during neurofeedback training (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 7 Oct 2025.