Enhancing Emotion Regulation Through Functional Near-infrared Spectroscopy (fNIRS)-Informed Real-time Neurofeedback

March 24, 2025 updated by: University of Electronic Science and Technology of China

Enhancing Emotion Regulation Through fNIRS-informed Real-time Neurofeedback

The present study aims to employ real-time functional near-infrared spectroscopy (fNIRS) neurofeedback training in combination with cognitive reappraisal strategies for regulating negative emotions in healthy individuals.

Participants will complete:

  • Cognitive reappraisal training with either real neurofeedback or sham feedback.
  • Questionnaires at pre- and post- training timepoints
  • A cold-pressor test at the end of the training

It is hypothesized that combining real-time fNIRS neurofeedback and cognitive reappraisal training will enhance emotion regulation in healthy individuals:

  1. Increased neural activity in the prefrontal cortex (PFC) region of the brain will be significantly higher in the real neurofeedback group after training compared to the sham feedback group.
  2. Real-time fNIRS-guided upregulation of the PFC will enhance emotion regulation during exposure to negative stimuli/scenes across the training runs.
  3. The effects of fNIRS neurofeedback training will extend to influence emotion regulation in a cold-pressor test administered post-training, wherein individuals in the real neurofeedback group demonstrate better regulation of stress and pain induced by the task.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The prevalence of stress-related disorders such as major depression and anxiety disorders has increased among children, adolescents and young adults internationally. Despite increasing concerns about the tremendous personal and societal toll of this development, efficacious interventions to reduce the detrimental impact of stress in young individuals are lacking. Therefore, working towards developing innovative approaches for regulating negative emotional experiences has substantial implications for addressing the prevailing mental health challenges affecting communities on a local and global scale.

Neurofeedback is a promising non-invasive neuromodulation technique allowing individuals to rapidly learn volitional control over brain activity via providing real-time feedback on brain function. Initial studies suggest that neurofeedback for emotion regulation produces increased experiences of positive emotion in patients with depression and decreased anxious mood in patients with anxiety disorder. A limitation of existing studies, however, is that neurofeedback training is often not directed with a concrete strategy that can help participants better learn control over brain activity, and extend learning outside of the experimental context.

Cognitive reappraisal, an emotion regulation strategy that focuses on reevaluating and changing the interpretation of an aversive scene or stimulus to reduce its negative impact on an individuals' emotions, has been implemented in several neurofeedback studies. It is shown to be effective in reducing negative emotions in clinical populations, such as in depression, anxiety, and trauma disorders when combined with fMRI neurofeedback. Meta-analytic evidence points to the lateral prefrontal cortex (lPFC) as a common region active during cognitive reappraisal. Thus, lPFC regions are a promising target for emotion regulation that has otherwise not been a target in existing studies, which traditionally focus on modulating emotional reactivity via subcortical regions.

Nevertheless, the implementation of neurofeedback-guided training on cortical level regions is relatively scarce, and even more so for improving emotion regulation in non-clinical populations. In our own previous studies, it has been previously demonstrated that healthy subjects can learn to control the activity of brain regions involved in emotional processing and that this can reduce anxiety. This suggests there is a promising potential of fNIRS neurofeedback training in combination with cognitive reappraisal strategies as a novel approach with broader implications for regulating stress in both clinical and non-clinical populations.

The present study aims to employ real-time fNIRS neurofeedback training in combination with cognitive reappraisal strategies for regulating negative emotions in healthy individuals. Participants will undergo cognitive reappraisal training with either real neurofeedback or sham feedback. Furthermore, emotion regulation ability will be assessed prior to and after neurofeedback training, through pre- and post-test behavioral measures and from comparing performance between real neurofeedback and sham feedback groups on a post-training task inducing physiological stress.

Participants will be explicitly instructed to apply cognitive reappraisal to upregulate brain activity. Prior to the neurofeedback runs, they will receive training illustrating the concept of cognitive reappraisal and neural basis of emotion regulation.

The present study will apply double-blinding. Participants will complete the experiment without knowing the presence of a control condition. The instructions administered to both groups will be exactly the same, and the experimenter responsible for administering instructions to the participant will not be aware of the participant's assigned group.

Study Type

Interventional

Enrollment (Estimated)

50

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 Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Hong Kong Jockey Club Building For Interdisciplinary Research, 5 Sassoon Rd, Sandy Bay
        • Contact:
          • Michelle Tsang
          • Phone Number: +852 3917 7126
          • Email: ncam@hku.hk

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:

  • Normal/corrected-to-normal vision
  • Right-handed
  • Below the cut-off for clinically-significant levels of depression (below 29) indicated by the Beck Depression Inventory (BDI-II; Beck et al., 1996)

Exclusion Criteria:

  • Current/history of mental health conditions
  • Current/history of chronic pain
  • The following conditions: Cardiovascular disorder, Raynaud's phenomenon, fainting, seizure, wounds on the hand/arm
  • Frequent use of alcohol/nicotine

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: fNIRS neurofeedback training group
Individuals in the fNIRS training group will receive feedback based on their real-time brain activity in the target region and learn to upregulate PFC activity while reappraising negative images.
Device: Real-time fNIRS neurofeedback from Turbo-Satori
Activity in the target brain region measured by fNIRS in real-time will undergo processing on Turbo-Satori (BrainVoyager; Maastricht, Netherlands) to infer changes in oxygenated blood activity in the target brain region and relayed to the task program for visual feedback.
Sham Comparator: Sham training group
Individuals in the sham training group will receive yoked feedback from previous data acquired from another individual in real neurofeedback group while reappraising negative images.
Device: Yoked sham feedback from Turbo-Satori
Previous data acquired from another individual in the experimental group will be loaded into Turbo-Satori (BrainVoyager; Maastricht, Netherlands) software for preprocessing in real-time and relayed to the task program for visual feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurofeedback success on the neural level
Time Frame: 0 to 35 minutes following the start of the training
Activity in the trained target brain region as measured by concomitant fNIRS (oxygenated signal) will be assessed over the four training runs, changes will be analyzed with analysis of variance (ANOVA) models.
0 to 35 minutes following the start of the training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on emotion regulation
Time Frame: 50-60 minutes following the start of the training
Individuals will undergo an evaluated stress-induction procedure via the cold pressor test after the neurofeedback training. Effects on emotion regulation will be assessed using self-reported ratings of stress on visual analog scales ranging from 0-100 and analyzed using ANOVA models.
50-60 minutes following the start of the training
Effect on pain regulation
Time Frame: 50-60 minutes following the start of the training
Individuals will undergo an evaluated stress-induction procedure via the cold pressor test after the neurofeedback training. Effects on pain regulation will be assessed using self-reported ratings of pain on visual analog scales ranging from 0-100 and analyzed using ANOVA models.
50-60 minutes following the start of the training

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 8, 2024

Primary Completion (Estimated)

August 7, 2026

Study Completion (Estimated)

August 7, 2026

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HKU_NCAM_001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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