HealthyNCT07559656
Oxytocin's Effects on Real Time-fMRI Neurofeedback Training of Anterior Insula Activity
A study testing Intranasal oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The primary aim of this study is to investigate whether intranasal oxytocin can modulate the real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback training effects by facilitating the use of an interoceptive strategy. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Intranasal oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2026to 1 Oct 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
- Men only
- 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, Dr, 18111297596, yaoshuxia@uestc.edu.cn
About this study
Official title: Effects of Intransal Oxytocin on Real-time fMRI Neurofeedback Training of Anterior Insula Activity Using an Interoceptive Strategy
The primary aim of this study is to investigate whether intranasal oxytocin can modulate the real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback training effects by facilitating the use of an interoceptive strategy.
Read the detailed description
A randomized, double-blind, placebo-controlled between-subject design is employed in this study. A total of 80 healthy male participants are recruited and randomly assigned to two groups (oxytocin-OT vs. placebo-PLC). Participants self-administer either intranasal spray of oxytocin or placebo (24 IU). Both groups receive continuous real-time neurofeedback from the left anterior insula. Comparisons between the two groups are conducted to determine whether OT facilitates the neurofeedback effects.
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 at the behavioral level. 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. Neurofeedback training effects at the neural level were measured by anterior insula activity during training. 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). Participants are required to complete the Positive and Negative Affect Schedule (PANAS) once each before OT treatment, after OT treatment (before the neurofeedback training task), and after the neurofeedback training task to measure mood changes.
- Conditions
- Healthy
- Being tested
- Intranasal oxytocin, Intranasal placebo
- Keywords
- Oxytocin, 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.
Intranasal oxytocinDrug
Each subject will be assigned to intranasally administered 24-IU of oxytocin.
Intranasal placeboDrug
Each subject will be assigned to intranasally administered 24-IU of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | A single dose of 24 international units of oxytocin will be administered with 3 puffs of treatment to each nostril. Receives: Drug: Intranasal oxytocin |
| Placebo | Placebo comparator | A single dose of 24 international units of placebo will be administered with 3 puffs of treatment to each nostril. Receives: Drug: Intranasal placebo |
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 (4)
Pain empathy rating scores
Subjects are required to rate their empathic feelings 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 using 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
Functional connectivity of the anterior insula
Differences of functional connectivity of the anterior insula during neurofeedback training
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start26 Apr 2026 (estimated)
- Primary completion27 Sep 2026 (estimated)
- Study completion1 Oct 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT07559656
- Sponsor's protocol ID
- UESTC-neuSCAN-108
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Apr 2026
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intransal Oxytocin on Real-time fMRI Neurofeedback Training of Anterior Insula Activity Using an Interoceptive Strategy
- ClinicalTrials.gov ID
- NCT07559656
- Acronym / sponsor ID
- UESTC-neuSCAN-108
- Conditions
- Healthy
- Keywords
- Oxytocin, Real-time neurofeedback, Anterior insula, Interoceptive strategy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 26 Apr 2026 (estimated)
- Primary completion
- 27 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 30 Apr 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 primary aim of this study is to investigate whether intranasal oxytocin can modulate the real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback training effects by facilitating the use of an interoceptive strategy.
Detailed description
A randomized, double-blind, placebo-controlled between-subject design is employed in this study. A total of 80 healthy male participants are recruited and randomly assigned to two groups (oxytocin-OT vs. placebo-PLC). Participants self-administer either intranasal spray of oxytocin or placebo (24 IU). Both groups receive continuous real-time neurofeedback from the left anterior insula. Comparisons between the two groups are conducted to determine whether OT facilitates the neurofeedback effects.
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 at the behavioral level. 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. Neurofeedback training effects at the neural level were measured by anterior insula activity during training. 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). Participants are required to complete the Positive and Negative Affect Schedule (PANAS) once each before OT treatment, after OT treatment (before the neurofeedback training task), 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: Intranasal oxytocinA single dose of 24 international units of oxytocin will be administered with 3 puffs of treatment to each nostril. |
| Placebo | Placebo comparator | Drug: Intranasal placeboA single dose of 24 international units of placebo will be administered with 3 puffs of treatment to each nostril. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- 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 |
|---|---|---|
| Intranasal oxytocinEach subject will be assigned to intranasally administered 24-IU of oxytocin. | Drug | Oxytocin |
| Intranasal placeboEach subject will be assigned to intranasally administered 24-IU of placebo. | Drug | Placebo |
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.
4 secondary outcomes
Pain empathy rating scores
Time frame: 1 hour
Confidence rating scores of interoceptive sensitivity
Time frame: 1 hour
Interoceptive accuracy
Time frame: 10 minutes
Functional connectivity of the anterior insula
Time frame: 1 hour
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 30 Apr 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 Intranasal oxytocin 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 30 Apr 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). 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 30 Apr 2026.