DRUG
Intranasal oxytocin
Each subject will be assigned to intranasally administered 24-IU of oxytocin.
Status
Recruiting
Phase
Not applicable
Enrollment
80
Locations
1
Results
Not posted
Publications
0
Study 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.
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
DRUG
Each subject will be assigned to intranasally administered 24-IU of oxytocin.
DRUG
Each subject will be assigned to intranasally administered 24-IU of placebo.
Timeline
First posted
Apr 30, 2026
Study start
Apr 26, 2026
Primary completion
Sep 27, 2026
Study completion
Oct 1, 2026
Results posted
Not reported
Registry updated
Apr 30, 2026
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.
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
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
China. Showing up to 24 locations stored in the fast local snapshot.
University of Electronic Science and Technology of China
Chengdu, Sichuan, China
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Wake Forest University Health Sciences · Total Hip Arthroplasty
Phase 2
Enrolling by invitation
80
2026-07
Yale University · Pain · Pituitary Surgery
Phase 2
Not yet recruiting
75
2026-07
Medical University of South Carolina · PTSD · Alcohol Use Disorder
Phase 2
Completed
175
2026-07
University Hospital, Tours · Cervical Ripening · Unfavorable Cervix
Phase 3
Recruiting
1,494
2026-07
Icahn School of Medicine at Mount Sinai · Pregnancy · Labor
Phase 3
Recruiting
281
2026-07
Elizabeth Austen Lawson · Vasopressin Deficiency
Phase 1
Recruiting
40
2026-07
Massachusetts General Hospital · Arginine Vasopressin Deficiency · Oxytocin Deficiency
Early Phase 1
Recruiting
20
2026-07
Aalto University · Induction of Birth · Cervical Ripening
Not applicable
Recruiting
40
2026-07
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.