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NCT Number: NCT07559656

Oxytocin's Effects on Real Time-fMRI Neurofeedback Training of Anterior Insula Activity

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.

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Electronic Science and Technology of China

Chengdu, Sichuan, 611731, China

Location status: Recruiting

Location contact

Shuxia Yao, Dr

CONTACT

[email protected]

18111297596

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects without any past or present psychiatric or neurological disorders.

Exclusion criteria

  • 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).

Treatment and study plan

Intranasal oxytocin

Drug

Each subject will be assigned to intranasally administered 24-IU of oxytocin.

Intranasal placebo

Drug

Each subject will be assigned to intranasally administered 24-IU of placebo.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain empathy rating scores

    Time frame: 1 hour

    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.

  2. Confidence rating scores of interoceptive sensitivity

    Time frame: 1 hour

    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).

  3. Interoceptive accuracy

    Time frame: 10 minutes

    1/N Σ(1-(|actual heartbeats--reported heartbeats|) / actual heartbeats). N indicates the number of recording blocks.

  4. Functional connectivity of the anterior insula

    Time frame: 1 hour

    Differences of functional connectivity of the anterior insula during neurofeedback training

Study contacts

Contact information is provided by the study sponsor or research team.

Shuxia Yao, Dr

CONTACT

[email protected]

18111297596

Sponsors and collaborators

Lead sponsor

University of Electronic Science and Technology of China

Other

Registry information

Official study title

Effects of Intransal Oxytocin on Real-time fMRI Neurofeedback Training of Anterior Insula Activity Using an Interoceptive Strategy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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