Continuous vs. Intermittent Rt-fMRI Neurofeedback Training of the Anterior Insula

January 28, 2026 updated by: Shuxia Yao, University of Electronic Science and Technology of China

A Comparative Study of Continuous vs. Intermittent Real-time fMRI Neurofeedback in Regulating Anterior Insula Activity

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A double-blinded, placebo-controled, between-subject design is employed in this study. A total of 90 healthy subjects will be recruited and randomly assigned into the intermittent experimental group (EG1; N=30), which receives intermittent feedback from the left anterior insula after each block, the control group (CG; N=30) after each block, which receives sham feedback from the middle temporal gyrus (MTG), and the continuous expermiental group (EG2; N=30), which receives real-time feedback from the left anterior insula. Comparisons between the EG1 and the CG are used to validate the efficacy of intermittent neurofeedback and comparisons between the EG2 and the CG are used to determine the better neurofeedback type (intermittent vs. continuous).

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 on empathic responses. 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. 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). Subjects are asked to complete Positive and Negative Affect Schedule (PANAS) twice before and after the neurofeedback training task to measure mood changes.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 611731
        • Recruiting
        • University of Electronic Science and Technology of China
        • Contact:
          • Shuxia Yao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent neurofeedback training
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
real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)
Sham Comparator: Intermittent sham control
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
real-time fMRI sham neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)
Experimental: Continuous neurofeedback training
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
real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour
Pain empathy ratings scores
Time Frame: 1 hour
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confidence rating scores of interoceptive sensitivity
Time Frame: 1 hour
Subjects are asked to rate to what extent they can feel their heartbeat based on a Likert Scale ranging from 1-9 (1 = very low and 9 = very high)
1 hour
Interoceptive accuracy
Time Frame: 10 minutes
1/N Σ(1-(|actual heartbeats--reported heartbeats|) / actual heartbeats). N indicates the number of recording blocks.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Electronic Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2026

Primary Completion (Estimated)

June 6, 2026

Study Completion (Estimated)

June 8, 2027

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UESTC-neuSCAN-104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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