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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07389486
Enrollment
90
Registered
2026-02-05
Start date
2026-01-28
Completion date
2027-06-08
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Real-time neurofeedback, Anterior insula, Feedback types, Interoceptive processing

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.

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.

Interventions

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

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

Sponsors

University of Electronic Science and Technology of China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Neural activity of the anterior insula based on blood oxygen level-dependent (BOLD) signal1 hourThe anterior insula activity induced during the regulation block compared to the baseline block.
Pain empathy ratings scores1 hourSubjects 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.

Secondary

MeasureTime frameDescription
Confidence rating scores of interoceptive sensitivity1 hourSubjects 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)
Interoceptive accuracy10 minutes1/N Σ(1-(\|actual heartbeats--reported heartbeats\|) / actual heartbeats). N indicates the number of recording blocks.

Countries

China

Contacts

CONTACTShuxia Yao, Dr
yaoshuxia@uestc.edu.cn18111297596

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026