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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07559656
Enrollment
80
Registered
2026-04-30
Start date
2026-04-26
Completion date
2026-10-01
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Oxytocin, Real-time neurofeedback, Anterior insula, Interoceptive strategy

Brief 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.

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

DRUGIntranasal oxytocin

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

DRUGIntranasal placebo

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

Sponsors

University of Electronic Science and Technology of China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal1 hourThe anterior insula activity induced during the regulation block compared to the baseline block.

Secondary

MeasureTime frameDescription
Pain empathy rating scores1 hourSubjects 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 sensitivity1 hourSubjects 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 accuracy10 minutes1/N Σ(1-(\|actual heartbeats--reported heartbeats\|) / actual heartbeats). N indicates the number of recording blocks.
Functional connectivity of the anterior insula1 hourDifferences of functional connectivity of the anterior insula during neurofeedback training

Countries

China

Contacts

CONTACTShuxia Yao, Dr
yaoshuxia@uestc.edu.cn18111297596

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026