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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Intranasal oxytocin; Drug: Intranasal placebo

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuxia Yao, Dr; Phone Number: 18111297596; Email: yaoshuxia@uestc.edu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 611731
      • Recruiting
      • University of Electronic Science and Technology of China
      • Contact: Shuxia Yao, Dr; Phone Number: 18111297596; Email: yaoshuxia@uestc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxytocin; A single dose of 24 international units of oxytocin will be administered with 3 puffs of treatment to each nostril.	Drug: Intranasal oxytocin; Each subject will be assigned to intranasally administered 24-IU of oxytocin.
Placebo Comparator: Placebo; A single dose of 24 international units of placebo will be administered with 3 puffs of treatment to each nostril.	Drug: Intranasal placebo; Each subject will be assigned to intranasally administered 24-IU of placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interoceptive accuracy	1/N Σ(1-(|actual heartbeats--reported heartbeats|) / actual heartbeats). N indicates the number of recording blocks.	10 minutes
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.	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).	1 hour
Functional connectivity of the anterior insula	Differences of functional connectivity of the anterior insula during neurofeedback training	1 hour

Collaborators and Investigators

• Sponsor: University of Electronic Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Estimated): April 26, 2026
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Oxytocin; Real-time neurofeedback; Anterior insula; Interoceptive strategy
• Other Study ID Numbers: UESTC-neuSCAN-108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No