Current partner codePEPTIDESDE
NCT07559656·Not applicable·INTERVENTIONAL

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

Status

Recruiting

Phase

Not applicable

Enrollment

80

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Intranasal oxytocin

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

DRUG

Intranasal placebo

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

Timeline

From registration to results.

  1. First posted

    Apr 30, 2026

  2. Study start

    Apr 26, 2026

  3. Primary completion

    Sep 27, 2026

  4. Study completion

    Oct 1, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Apr 30, 2026

Outcomes

What the study measures.

Primary outcomes

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

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.

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).

Interoceptive accuracy

Time frame · 10 minutes

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

Functional connectivity of the anterior insula

Time frame · 1 hour

Differences of functional connectivity of the anterior insula during neurofeedback training

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
30 Years
Sex
MALE
Healthy volunteers
Yes

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).

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

University of Electronic Science and Technology of China

Chengdu, Sichuan, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Oxytocin.

Related PeptideStat pages

Put the record in context.

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