NCT07559656

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
5mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

April 23, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 26, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2026

Expected
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Healthy

Keywords

OxytocinReal-time neurofeedbackAnterior insulaInteroceptive strategy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Pain empathy rating scores

    1 hour

  • Confidence rating scores of interoceptive sensitivity

    1 hour

  • Interoceptive accuracy

    10 minutes

  • Functional connectivity of the anterior insula

    1 hour

Study Arms (2)

Oxytocin

EXPERIMENTAL

A single dose of 24 international units of oxytocin will be administered with 3 puffs of treatment to each nostril.

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.

Drug: Intranasal placebo

Interventions

Intranasal oxytocinDRUG

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

Oxytocin
Intranasal placeboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsIndividuals whose self-identified gender is consistent with their biological sex.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Electronic Science and Technology of China

Chengdu, Sichuan, 611731, China

RECRUITING

Central Study Contacts

Shuxia Yao, Dr

CONTACT

18111297596yaoshuxia@uestc.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 30, 2026

Study Start

April 26, 2026

Primary Completion (Estimated)

September 27, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

CN(1)