NCT07416370

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 28, 2026

Last Update Submit

February 14, 2026

Conditions

Keywords

real-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 (3)

  • Pain empathy ratings scores

    1 hour

  • Confidence rating scores of interoceptive sensitivity

    10 minutes

  • Interoceptive accuracy

    10 minutes

Study Arms (2)

Multidimensional interoception strategy with real-time fMRI neurofeedback

EXPERIMENTAL

Subjects in the multidimensional interoception group are instructed to regulate anterior insula activity based on visual neurofeedback using a multidimensional interoception strategy that engages four distinct, interrelated interoceptive signals: respiratory signals, heartbeat, gastric sensations, and bladder distension.

Device: real-time fMRI neurofeedback training

Heartbeat detection strategy with real-time fMRI neurofeedback

ACTIVE COMPARATOR

Subjects in the heartbeat detection group are instructed to regulate anterior insula activity based on visual neurofeedback by using a heartbeat detection strategy.

Device: real-time fMRI neurofeedback training

Interventions

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.

Also known as: rt-fMRI NF training
Heartbeat detection strategy with real-time fMRI neurofeedbackMultidimensional interoception strategy with real-time fMRI neurofeedback

Eligibility Criteria

Age18 Years - 30 Years
Sexall(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:

  • No past or current psychiatric or neurological or other main disorders.

You may not qualify if:

  • Current use of medications.
  • 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

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 18, 2026

Study Start

February 2, 2026

Primary Completion

May 16, 2026

Study Completion

May 18, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations