NCT07389486

Brief Summary

The main aim of this study is to compare the efficacy of intermittent with continuous real-time functional magnetic resonance imaging (fMRI) neurofeedback on anterior insula regulation and associated behavioral changes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Timeline
14mo left

Started Jan 2026

Typical duration for not_applicable healthy

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 Progress20%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

January 28, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2027

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 28, 2026

Last Update Submit

January 28, 2026

Conditions

Healthy

Keywords

Real-time neurofeedbackAnterior insulaFeedback typesInteroceptive processing

Outcome Measures

Primary Outcomes (2)

  • 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

  • Pain empathy ratings scores

    Subjects were required to rate their empathic feeling towards painful pictures on a Likert Scale ranging from 1-9 (1 = not at all and 9 = very painful) before and after neurofeedback training.

    1 hour

Secondary Outcomes (2)

  • Confidence rating scores of interoceptive sensitivity

    1 hour

  • Interoceptive accuracy

    10 minutes

Study Arms (3)

Intermittent neurofeedback training

EXPERIMENTAL

Subjects in the intermittent neurofeedback training group are instructed to regulate their anterior insula activity based on the visual neurofeedback after each regulation block. This intermittent neurofeedback is based on averaged activity of the anterior insula during the regulation block.

Procedure: real-time fMRI neurofeedback training procedure

Intermittent sham control

SHAM COMPARATOR

Subjects in the sham control group receive the same instruction but perform the regulation based on sham neurofeedback from the middle temporal gyrus (a controlled sham region).

Procedure: real-time fMRI sham-controlled neurofeedback training procedure

Continuous neurofeedback training

EXPERIMENTAL

Subjects in the continuous neurofeedback training group are instructed to regulate their anterior insula activity based on the real-time visual neurofeedback during regulation blocks.

Procedure: real-time fMRI neurofeedback training procedure

Interventions

real-time fMRI sham-controlled neurofeedback training procedurePROCEDURE

real-time fMRI sham neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)

Intermittent sham control
real-time fMRI neurofeedback training procedurePROCEDURE

real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)

Intermittent neurofeedback training

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:

  • 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

January 28, 2026

First Posted

February 5, 2026

Study Start

January 28, 2026

Primary Completion (Estimated)

June 6, 2026

Study Completion (Estimated)

June 8, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Locations

CN(1)