Oxytocin's Effects on Real Time-fMRI Neurofeedback Training of Anterior Insula Activity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intranasal oxytocin, Intranasal placebo.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 30 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Intransal Oxytocin on Real-time fMRI Neurofeedback Training of Anterior Insula Activity Using an Interoceptive Strategy
Overview
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
- 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.
Primary outcome measures
- Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal [Time frame: 1 hour]
Secondary outcome measures (4)
- Pain empathy rating scores [Time frame: 1 hour]
- Confidence rating scores of interoceptive sensitivity [Time frame: 1 hour]
- Interoceptive accuracy [Time frame: 10 minutes]
- Functional connectivity of the anterior insula [Time frame: 1 hour]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
China · 1 center
- University of Electronic Science and Technology of China — Chengdu
Identifiers
NCT: NCT07559656 · UESTC-neuSCAN-108