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NeurofeedbackNCT06866028

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

A study testing Real-time fNIRS neurofeedback from Turbo-Satori in people with Neurofeedback and Emotion Regulation, run by University of Electronic Science and Technology of China at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Neurofeedback, Emotion Regulation, Stress
What is being tested?
Real-time fNIRS neurofeedback from Turbo-Satori
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteHong Kong
Study dates
8 Aug 2024to 7 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Kong1 site, 1 recruiting
  • The Hong Kong Jockey Club Building For Interdisciplinary Research, 5 Sassoon Rd, Sandy Bay

    Hong Kong

    Michelle Tsang, +852 3917 7126, ncam@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: 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:

Read more
  • 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.
Read the 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.

Being tested
Real-time fNIRS neurofeedback from Turbo-Satori, Yoked sham feedback from Turbo-Satori
Keywords
fNIRS, emotion, neurofeedback
Medical subject headings
Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Real-time fNIRS neurofeedback from Turbo-SatoriDevice

    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.

  • Yoked sham feedback from Turbo-SatoriDevice

    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.

Study groups in NCT06866028
Study groupRoleWhat they receive
fNIRS neurofeedback training groupExperimentalIndividuals 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.
Receives: Device: Real-time fNIRS neurofeedback from Turbo-Satori
Sham training groupSham comparatorIndividuals in the sham training group will receive yoked feedback from previous data acquired from another individual in real neurofeedback group while reappraising negative images.
Receives: Device: Yoked sham feedback from Turbo-Satori

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurofeedback success on the neural level

    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.

    Measured: 0 to 35 minutes following the start of the training

Secondary outcomes (2)
  1. Effect on emotion regulation

    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.

    Measured: 50-60 minutes following the start of the training

  2. Effect on pain regulation

    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.

    Measured: 50-60 minutes following the start of the training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start8 Aug 2024
  3. Primary completion7 Aug 2026 (estimated)
  4. Study completion7 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized sham-controlled parallel group fNIRS neurofeedback trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06866028
Sponsor's protocol ID
HKU_NCAM_001
Status last verified
Mar 2025
First submitted
4 Mar 2025
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zweerings J, Sarkheil P, Keller M, Dyck M, Klasen M, Becker B, Gaebler AJ, Ibrahim CN, Turetsky BI, Zvyagintsev M, Flatten G, Mathiak K. Rt-fMRI neurofeedback-guided cognitive reappraisal training modulates amygdala responsivity in posttraumatic stress disorder. Neuroimage Clin. 2020;28:102483. doi: 10.1016/j.nicl.2020.102483. Epub 2020 Oct 28.

    PubMed 33395974
  • Zilverstand A, Sorger B, Sarkheil P, Goebel R. fMRI neurofeedback facilitates anxiety regulation in females with spider phobia. Front Behav Neurosci. 2015 Jun 8;9:148. doi: 10.3389/fnbeh.2015.00148. eCollection 2015.

    PubMed 26106309
  • Zilverstand A, Parvaz MA, Goldstein RZ. Neuroimaging cognitive reappraisal in clinical populations to define neural targets for enhancing emotion regulation. A systematic review. Neuroimage. 2017 May 1;151:105-116. doi: 10.1016/j.neuroimage.2016.06.009. Epub 2016 Jun 8.

    PubMed 27288319
  • Zhao Z, Yao S, Zweerings J, Zhou X, Zhou F, Kendrick KM, Chen H, Mathiak K, Becker B. Putamen volume predicts real-time fMRI neurofeedback learning success across paradigms and neurofeedback target regions. Hum Brain Mapp. 2021 Apr 15;42(6):1879-1887. doi: 10.1002/hbm.25336. Epub 2021 Jan 5.

    PubMed 33400306
  • Zhao Z, Yao S, Li K, Sindermann C, Zhou F, Zhao W, Li J, Luhrs M, Goebel R, Kendrick KM, Becker B. Real-Time Functional Connectivity-Informed Neurofeedback of Amygdala-Frontal Pathways Reduces Anxiety. Psychother Psychosom. 2019;88(1):5-15. doi: 10.1159/000496057. Epub 2019 Jan 30.

    PubMed 30699438
  • Yao S, Becker B, Geng Y, Zhao Z, Xu X, Zhao W, Ren P, Kendrick KM. Voluntary control of anterior insula and its functional connections is feedback-independent and increases pain empathy. Neuroimage. 2016 Apr 15;130:230-240. doi: 10.1016/j.neuroimage.2016.02.035. Epub 2016 Feb 17.

    PubMed 26899786
  • Pico-Perez M, Radua J, Steward T, Menchon JM, Soriano-Mas C. Emotion regulation in mood and anxiety disorders: A meta-analysis of fMRI cognitive reappraisal studies. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Oct 3;79(Pt B):96-104. doi: 10.1016/j.pnpbp.2017.06.001. Epub 2017 Jun 1.

    PubMed 28579400
  • COVID-19 Mental Disorders Collaborators. Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the COVID-19 pandemic. Lancet. 2021 Nov 6;398(10312):1700-1712. doi: 10.1016/S0140-6736(21)02143-7. Epub 2021 Oct 8.

    PubMed 34634250
  • Linhartova P, Latalova A, Kosa B, Kasparek T, Schmahl C, Paret C. fMRI neurofeedback in emotion regulation: A literature review. Neuroimage. 2019 Jun;193:75-92. doi: 10.1016/j.neuroimage.2019.03.011. Epub 2019 Mar 9.

    PubMed 30862532
  • Keller M, Zweerings J, Klasen M, Zvyagintsev M, Iglesias J, Mendoza Quinones R, Mathiak K. fMRI Neurofeedback-Enhanced Cognitive Reappraisal Training in Depression: A Double-Blind Comparison of Left and Right vlPFC Regulation. Front Psychiatry. 2021 Aug 23;12:715898. doi: 10.3389/fpsyt.2021.715898. eCollection 2021.

    PubMed 34497546
  • Gross JJ. Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. doi: 10.1017/s0048577201393198.

    PubMed 12212647
  • Buhle JT, Silvers JA, Wager TD, Lopez R, Onyemekwu C, Kober H, Weber J, Ochsner KN. Cognitive reappraisal of emotion: a meta-analysis of human neuroimaging studies. Cereb Cortex. 2014 Nov;24(11):2981-90. doi: 10.1093/cercor/bht154. Epub 2013 Jun 13.

    PubMed 23765157

Questions about this trial

What is this clinical trial studying?

A study testing Real-time fNIRS neurofeedback from Turbo-Satori in people with Neurofeedback and Emotion Regulation, run by University of Electronic Science and Technology of China at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurofeedback success on the neural level (time frame: 0 to 35 minutes following the start of the training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06866028, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.

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