Trials / Enrolling By Invitation
Enrolling By InvitationNCT07416370
Neurofeedback Training of Anterior Insula Activity Based on Unidimensional vs. Multidimensional Interoceptive Regulation Strategies
A Comparative Study of Anterior Insula Real-time fMRI Neurofeedback Training Based on Unidimensional vs. Multidimensional Interoceptive Regulation Strategies
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- University of Electronic Science and Technology of China · Academic / Other
- Sex
- All
- Age
- 18 Years – 30 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to compare the neural and behavioral effects of real-time functional magnetic resonance imaging (fMRI) neurofeedback training using two different interoceptive strategies: a unidimensional heartbeat detection strategy and a multidimensional interoception strategy. Specifically, the study compares the efficacy of these two regulation strategies in regulating activity of the anterior insula, a key brain region involved in interoceptive and emotional processing.
Detailed description
This study uses a randomized between-subject design to compare the efficacy of two interoceptive strategies in regulating anterior insula activity during real-time fMRI neurofeedback training. A total of 60 healthy participants are recruited and are randomly assigned to one of two groups. The heartbeat detection group (HDG; n = 30) uses a heartbeat detection strategy to upregulate anterior insula activity during neurofeedback training. The multidimensional interoception group (MIG; n = 30) uses a multidimensional interoception strategy which involves shifting attention among respiratory sensations, cardiac signals, gastric sensations, and bladder distension, to increase anterior insula activity during neurofeedback training. The neurofeedback protocol includes 4 training sessions with real-time neurofeedback and 1 transfer session without neurofeedback. Each session comprises 6 regulation (upregulate anterior insula activity with interoception strategies) blocks and 6 baseline (rest) blocks. Interoceptive accuracy is assessed using a heartbeat detection task performed before and after neurofeedback training. During MRI scanning, a heartbeat counting task will be employed prior to neurofeedback training to localize the anterior insula. The behavioral effects of neurofeedback training are evaluated using a pain empathy rating task and an interoception/relaxation rating task following the regulation or baseline block. Individual differences in personality traits and interoceptive characteristics are assessed using validated Chinese questionnaires, including State-Trait Anxiety Inventory (STAI), Beck Depression Inventory-Ⅱ (BDI-Ⅱ), Toronto Alexithymia Scale (TAS), Autism Spectrum Quotient (ASQ), Bermond-Vorst Alexithymia Questionnaire (BVAQ), Multidimensional Assessment of Interoceptive Awareness (MAIA), Interoceptive Confusion Questionnaire (ICQ), Interpersonal Reactivity Index (IRI), and Cognitive Flexibility Inventory (CFI). Affective moods are assessed using the Positive and Negative Affect Schedule (PANAS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | real-time fMRI neurofeedback training | Real-time neurofeedback information is computed using the Turbo Brain voyager (TBV) 4.0 software (Brain Innovation, Maastricht, The Netherlands). Functional images are collected and processed in real time based on contrasts of regulation vs. rest conditions. The blood oxygen level dependent (BOLD) signal of the target region is then transformed into visual bars and displayed to participants via the projector screen. Both groups will undergo the same paradigm, but with different interoception strategies. |
Timeline
- Start date
- 2026-02-02
- Primary completion
- 2026-05-16
- Completion
- 2026-05-18
- First posted
- 2026-02-18
- Last updated
- 2026-02-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07416370. Inclusion in this directory is not an endorsement.