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

NCT06866028 | Recruiting

• 1 other identifier: HKU_NCAM_001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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:
• 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.
• Real-time fNIRS-guided upregulation of the PFC will enhance emotion regulation during exposure to negative stimuli/scenes across the training runs.
• 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.

Conditions

Neurofeedback; Emotion Regulation; Stress

Keywords

fNIRS; emotion; neurofeedback

Outcome Measures

Primary Outcomes (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.

  0 to 35 minutes following the start of the training

Secondary Outcomes (2)

• Effect on emotion regulation

  50-60 minutes following the start of the training

• Effect on pain regulation

  50-60 minutes following the start of the training

Study Arms (2)

fNIRS neurofeedback training group

EXPERIMENTAL

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

Sham training group

SHAM COMPARATOR

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

Interventions

Real-time fNIRS neurofeedback from Turbo-Satori DEVICE

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.

fNIRS neurofeedback training group

Yoked sham feedback from Turbo-Satori DEVICE

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.

Sham training group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

The Hong Kong Jockey Club Building For Interdisciplinary Research, 5 Sassoon Rd, Sandy Bay

Hong Kong, Hong Kong

RECRUITING

Related Publications (12)

• 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.

  PMID: 33395974 BACKGROUND

• 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.

  PMID: 26106309 BACKGROUND

• 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.

  PMID: 27288319 BACKGROUND

• 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.

  PMID: 33400306 BACKGROUND

• 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.

  PMID: 30699438 BACKGROUND

• 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.

  PMID: 26899786 BACKGROUND

• 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.

  PMID: 28579400 BACKGROUND

• 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.

  PMID: 34634250 BACKGROUND

• 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.

  PMID: 30862532 BACKGROUND

• 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.

  PMID: 34497546 BACKGROUND

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

  PMID: 12212647 BACKGROUND

• 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.

  PMID: 23765157 BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

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: SPONSOR

Model Details: Randomized sham-controlled parallel group fNIRS neurofeedback trial

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: August 8, 2024
• Primary Completion (Estimated): August 7, 2026
• Study Completion (Estimated): August 7, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

HK (1)