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| ID | Type | Description | Link |
|---|---|---|---|
| ITS/077/22 | Other Grant/Funding Number | Innovation and Technology Commission |
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| Name | Class |
|---|---|
| HOME Psychological Services Ltd. | UNKNOWN |
| ANT Asia Pacific | UNKNOWN |
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The goal of this study is to learn if a new brain training method, called combined electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) neurofeedback, can improve thinking, emotions, and social functioning in children with autism spectrum disorder (ASD). It will also learn if this training is practical and safe to use with children in Hong Kong.
The main questions this study aims to answer are:
Participants will:
.Receive sessions of EEG-fNIRS neurofeedback training. .Complete assessments of thinking skills, emotional regulation, and social functioning before and after training.
Autism spectrum disorder (ASD) is a lifelong neurodevelopmental condition characterized by difficulties in social communication and interaction, often accompanied by cognitive and emotional regulation challenges. In Hong Kong and many other countries, ASD is increasingly prevalent. Despite this, the brain health of autistic individuals has been relatively neglected in both healthcare systems and public policies. There is also a lack of approaches and technologies that directly intervene with brain function. Since many autistic children experience poor vocational and health outcomes in adulthood, there is a strong need to develop effective and accessible neuroscience-based treatments.
This project aims to apply cutting-edge neuroscientific methods to develop an innovative closed-loop brain training intervention for children with ASD. The intervention will combine electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) in a unified neurofeedback training system. Neurofeedback training teaches individuals to self-regulate brain activity by providing real-time feedback. In the traditional neurofeedback study, EEG has been used to guide neurofeedback by monitoring electrical activity in the brain, while more recently fNIRS has been used to track hemodynamic activity. However, no existing neurofeedback system has integrated these two modalities. Combining EEG and fNIRS provides an opportunity to enhance neurovascular coupling, the relationship between neural activity and blood flow, which is often altered in neuropsychiatric conditions such as autism.
The proposed neurofeedback application will include multiple training modules designed to address cognitive, emotional, and social difficulties common in autism. The cognitive training module will target brain activity patterns associated with attention and executive function. The affective training module will focus on modulating frontal brain activity linked to emotional regulation. The social training module will aim to enhance neural and hemodynamic activity associated with social cognition and communication. By integrating both EEG and fNIRS indices, the system will encourage children to regulate electrical and hemodynamic activity simultaneously, which cannot be achieved using either modality alone.
To maximize engagement, the application will incorporate ecologically valid feedback stimuli and reward-based learning principles. Instead of relying solely on abstract indicators such as bars or tones, the feedback will involve intrinsically rewarding stimuli, such as videos or positive visual cues, to increase motivation and adherence. The training difficulty will be adjusted progressively based on individual performance to ensure sustained engagement and improvement.
In addition, the system will be developed as a cross-device application using open-source lab streaming layer (LSL) software, ensuring compatibility with a wide range of EEG and fNIRS devices. The hardware and software will be optimized to ensure high-quality signals, including the use of shielded wet electrodes for EEG to reduce noise and short-separation channels in fNIRS to minimize extracerebral signal contamination. These features will allow neurofeedback training to be conducted with minimal environmental interference, enhancing both reliability and clinical applicability.
Through this proof-of-concept project, this project aims to establish the feasibility of combined EEG-fNIRS neurofeedback as a novel form of brain training for autistic children. If successful, this approach has the potential to offer a comprehensive, technology-based neurorehabilitation solution that can improve functional outcomes, reduce healthcare burdens, and foster innovation in neurotechnology in Hong Kong.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined EEG-fNIRS group | Experimental | The participants will undertake two essential phases of neurofeedback training: (1) baseline and (2) training. During baseline phase (typically 3 minutes), the user plays the default neurofeedback game to obtain baseline EEG and fNIRS recordings. On the basis of these signals, the mean and standard deviation of the index of interest will be extracted and calculated. During the training phase (typically 5 minutes), the signal processing is almost identical to the one during baseline phase, but the moment-to-moment outcome variable will be Z-normalized according to the mean and SD of the target index. Once the data is pushed to the LSL stream for use in neurofeedback game interaction, participants can see the corresponding changes in the game screen. For the combined EEG-fNIRS group, both the EEG and fNIRS indices will be be extracted. To encourage integration, the lower value of the two will be chosen as the outcome variable. |
|
| EEG group | Experimental | The participants will undertake two essential phases of neurofeedback training: (1) baseline and (2) training. During baseline phase (typically 3 minutes), the user plays the default neurofeedback game to obtain baseline EEG and fNIRS recordings. On the basis of these signals, the mean and standard deviation of the index of interest will be extracted and calculated. During the training phase (typically 5 minutes), the signal processing is almost identical to the one during baseline phase, but the moment-to-moment outcome variable will be Z-normalized according to the mean and SD of the target index. Once the data is pushed to the LSL stream for use in neurofeedback game interaction, participants can see the corresponding changes in the game screen. For EEG, the frontal theta/beta ratio, left-right difference in frontal alpha power, and the mu power are chosen as the target training indices. |
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| fNIRS group | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG and fNIRS | Device | For EEG and fNIRS, EEG signals will be recorded using the ANT Neuro eego rt 8 amplifier device (ANT Neuro, Hengelo, The Netherlands), with electrodes placed at C3, C4, F3, F4, Fpz, M1, M2, and GND (ground). fNIRS signals will be recorded using the Artinis Brite Lite fNIRS device(Artinis Medical Systems, The Netherlands). The overall channel configuration consists of eight sources and four detectors. Among these, four sources (T2a-d) and four detectors (R1-4) form four short-separation channels, while the remaining four sources and four detectors constitute six long-separation channels (T1-R1, T3-R1, T3-R2, T4-R3, T5-R3, T5-R4). The overall configuration is approximately arranged in two L-shaped layouts surrounding the F3 and F4 regions. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of treatments for autistic individuals | The Autism Treatment Evaluation Checklist (ATEC) assesses the effectiveness of treatments for autistic individuals. It is completed by parent and consists of four subscales in different aspects of functioning, including Speech/Language/Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior. Parents are required to answer each question using a 3-point scale ranging from 0 (not true) to 2 (true). The checklist can typically be completed in about 5 minutes. | Within 1 week before the first training session, and within 1 week after the last training session |
| Social behavior and Social impairments | The Social Responsiveness Scale, Second Edition (SRS-2) is a 65-item questionnaire designed to assess social behavior and identify social impairments associated with autism spectrum disorders. It is completed by parent and evaluates 5 subscales, including social awareness, social cognition, social communication, social motivation, and restricted interests and repetitive behaviors. Respondents rate each item on a 4-point Likert scale, ranging from 0 (not true) to 3 (always true), reflecting the frequency and severity of observed behaviors. The questionnaire can typically be completed in around 10 minutes. | Within 1 week before the first training session, and within 1 week after the last training session |
| Executive function in children and adolescents | The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) is a 63-item questionnaire designed to assess executive function in children and adolescents. It is completed by parent and evaluates subscales such as behavioral regulation, emotional control, and cognitive processes. Respondents rate each item on a 3-point scale ranging from 1 (never) to 3 (often), indicating the frequency of behaviors. The questionnaire can typically be completed in around 15 minutes. | Within 1 week before the first training session, and within 1 week after the last training session |
| Anxiety and depression symptoms in children and adolescents |
| Measure | Description | Time Frame |
|---|---|---|
| Go/No-go(post; RT) | Change in Go/No-go mean reaction time | Within 1 week before the first training session, and within 1 week after the last training session |
| Go/No-go (post; Accuracy) | Change in Go/No-go accuracy |
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Inclusion Criteria:
Exclusion Criteria:
- Not meeting any of the above inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kin Chung Michael Yeung, PhD | Education University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Education And Human Development OF The Educational University Of Hong Kong | Hong Kong | Hong Kong | 000000 | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31302517 | Result | Wang SY, Lin IM, Fan SY, Tsai YC, Yen CF, Yeh YC, Huang MF, Lee Y, Chiu NM, Hung CF, Wang PW, Liu TL, Lin HC. The effects of alpha asymmetry and high-beta down-training neurofeedback for patients with the major depressive disorder and anxiety symptoms. J Affect Disord. 2019 Oct 1;257:287-296. doi: 10.1016/j.jad.2019.07.026. Epub 2019 Jul 5. | |
| 29445867 |
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All data related to this study will be kept strictly confidential and will be accessible only to the research team for research purposes. Study findings may be published in academic journals or presented at conferences; however, the names of participants and their families will remain confidential. All assessment instruments will be identified by coded numbers rather than names, and all personal information will be stored in a locked filing cabinet until the fifth year following the dissemination of study results. The Confidentiality and Privacy Ordinance of The Educational University Of Hong Kong shall protect and keep all medical data.
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D002659 | Child Development Disorders, Pervasive |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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The participants will be randomly and equally assigned to one of three neurofeedback training groups: (1) Combined EEG-fNIRS, (2) EEG, and (3) fNIRS. Each participant will complete a neurophysiological assessment (1) before and (2) immediately after a 12-session program (two 1-hour sessions per week).
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During each training session, a cap adjusted to the participant's head size will be used to mount the EEG and fNIRS sensors. The hardware setup will be the same for all groups to ensure that both the participant and experimenter are blinded to the training group. Besides, all participants will be identified by numbers, which are randomly assigned to one of three conditions by the Principal Investigator, who does not involve in either the assessment or training session.
The participants will undertake two essential phases of neurofeedback training: (1) baseline and (2) training. During baseline phase (typically 3 minutes), the user plays the default neurofeedback game to obtain baseline EEG and fNIRS recordings. On the basis of these signals, the mean and standard deviation of the index of interest will be extracted and calculated. During the training phase (typically 5 minutes), the signal processing is almost identical to the one during baseline phase, but the moment-to-moment outcome variable will be Z-normalized according to the mean and SD of the target index. Once the data is pushed to the LSL stream for use in neurofeedback game interaction, participants can see the corresponding changes in the game screen. For fNIRS, the level of prefrontal activation (HbO or HbR), the left-right difference in prefrontal activation, and the motor cortex activation are chosen as the target training indices, respectively. |
|
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| EEG | Device | EEG signals will be recorded using the ANT Neuro eego rt 8 amplifier device (ANT Neuro, Hengelo, The Netherlands), with electrodes placed at C3, C4, F3, F4, Fpz, M1, M2, and GND (ground). |
|
| fNIRS | Device | fNIRS signals will be recorded using the Artinis Brite Lite fNIRS device(Artinis Medical Systems, The Netherlands). The overall channel configuration consists of eight sources and four detectors. Among these, four sources (T2a-d) and four detectors (R1-4) form four short-separation channels, while the remaining four sources and four detectors constitute six long-separation channels (T1-R1, T3-R1, T3-R2, T4-R3, T5-R3, T5-R4). The overall configuration is approximately arranged in two L-shaped layouts surrounding the F3 and F4 regions. |
|
The Revised Children's Anxiety and Depression Scale-Parent Version (RCADS-P) is a 25-item questionnaire designed to assess anxiety and depression symptoms in children and adolescents. Completed by parent, it evaluates key emotional domains, including generalized anxiety, panic disorder, separation anxiety, social phobia, obsessive-compulsive disorder, and major depressive disorder. Parents rate each item based on their child's recent behavior using a 4-point Likert scale: 0 (never), 1 (sometimes), 2 (often), and 3 (always), reflecting the frequency of symptoms. The checklist can typically be completed in around 3 minutes. |
| Within 1 week before the first training session, and within 1 week after the last training session |
| Within 1 week before the first training session, and within 1 week after the last training session |
| Sternberg Working Memory Task (post; RT) | Change in Sternberg task mean reaction time | Within 1 week before the first training session, and within 1 week after the last training session |
| Sternberg Working Memory Task (post; Accuracy) | Change in Sternberg task accuracy | Within 1 week before the first training session, and within 1 week after the last training session |
| Task Switching (post; RT) | Change in Task Switching mean reaction time | Within 1 week before the first training session, and within 1 week after the last training session |
| Task Switching (post; Accuracy) | Change in Task Switching accuracy | Within 1 week before the first training session, and within 1 week after the last training session |
| Child Eyes Test (post; RT) | Change in Child Eyes Test mean reaction time | Within 1 week before the first training session, and within 1 week after the last training session |
| Child Eyes Test (post; Accuracy) | Change in Child Eyes Test accuracy | Within 1 week before the first training session, and within 1 week after the last training session |
| Facial Emotion Recognition Task (post; RT) | Change in Facial Emotion Recognition mean reaction time | Within 1 week before the first training session, and within 1 week after the last training session |
| Facial Emotion Recognition Task (post; Accuracy) | Change in Facial Emotion Recognition accuracy | Within 1 week before the first training session, and within 1 week after the last training session |
| Van Doren J, Arns M, Heinrich H, Vollebregt MA, Strehl U, K Loo S. Sustained effects of neurofeedback in ADHD: a systematic review and meta-analysis. Eur Child Adolesc Psychiatry. 2019 Mar;28(3):293-305. doi: 10.1007/s00787-018-1121-4. Epub 2018 Feb 14. |
| 33587957 | Result | Trambaiolli LR, Kohl SH, Linden DEJ, Mehler DMA. Neurofeedback training in major depressive disorder: A systematic review of clinical efficacy, study quality and reporting practices. Neurosci Biobehav Rev. 2021 Jun;125:33-56. doi: 10.1016/j.neubiorev.2021.02.015. Epub 2021 Feb 12. |
| Result | The Government of the Hong Kong Special Administrative Region. (2019). EDB to enhance support for students with autism spectrum disorders. Retrieved August 24, 2022, from https://www.info.gov.hk/gia/general/201910/03/P2019100300291.htm?fontSize=1. |
| 32093790 | Result | Steingrimsson S, Bilonic G, Ekelund AC, Larson T, Stadig I, Svensson M, Vukovic IS, Wartenberg C, Wrede O, Bernhardsson S. Electroencephalography-based neurofeedback as treatment for post-traumatic stress disorder: A systematic review and meta-analysis. Eur Psychiatry. 2020 Jan 31;63(1):e7. doi: 10.1192/j.eurpsy.2019.7. |
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| Result | Russo, G. M., Balkin, R. S., & Lenz, A. S. (2022). A meta-analysis of neurofeedback for treating anxiety-spectrum disorders. Journal of Counseling & Development, 100(3), 236-251. |
| 35714757 | Result | Rosson S, de Filippis R, Croatto G, Collantoni E, Pallottino S, Guinart D, Brunoni AR, Dell'Osso B, Pigato G, Hyde J, Brandt V, Cortese S, Fiedorowicz JG, Petrides G, Correll CU, Solmi M. Brain stimulation and other biological non-pharmacological interventions in mental disorders: An umbrella review. Neurosci Biobehav Rev. 2022 Aug;139:104743. doi: 10.1016/j.neubiorev.2022.104743. Epub 2022 Jun 14. |
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| Result | Pineda, J. A., Brang, D., Hecht, E., Edwards, L., Carey, S., Bacon, M., ... & Rork, A. (2008). Positive behavioral and electrophysiological changes following neurofeedback training in children with autism. Research in Autism Spectrum Disorders, 2(3), 557-581. |
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