AutismNCT07149974
Neurofeedback Training for Autistic Children
A study testing EEG and fNIRS, EEG and fNIRS in people with Autism and Autistic Disorders Spectrum, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Autism, Autistic Disorders Spectrum, Neurofeedback
- What is being tested?
- EEG and fNIRS, EEG and fNIRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2025to 31 Jan 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 8 to 12 years
- Previous diagnosis of autism spectrum disorder (ASD) or Asperger's syndrome
- No intellectual impairment or studying in mainstream schools
- Right-handedness
- Normal or corrected-to-normal vision
Who cannot join
- Not meeting any of the above inclusion criteria
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
Faculty of Education And Human Development OF The Educational University Of Hong Kong
Hong Kong, Hong Kong, 000000
About this study
Official title: Developing an EEG-fNIRS Neurofeedback Application for Brain Training for Autistic Children
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:
Read more
- Does combined EEG-fNIRS neurofeedback improve attention, emotion regulation, and social skills in children with ASD?
- Is this type of neurofeedback training feasible and well-tolerated by children? Researchers will compare the new combined EEG-fNIRS training with single EEG or fNIRS training to see if it provides additional benefits.
Participants will:
.Receive sessions of EEG-fNIRS neurofeedback training. .Complete assessments of thinking skills, emotional regulation, and social functioning before and after training.
Read the detailed description
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.
- Conditions
- Autism, Autistic Disorders Spectrum, Neurofeedback, EEG, fNIRS
- Being tested
- EEG and fNIRS, EEG, fNIRS
- Keywords
- ASD, Autistic, Neurofeedback, EEG, fNIRS
- Medical subject headings
- Autistic Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG and fNIRSDevice
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.
EEGDevice
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).
fNIRSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EEG and fNIRS |
| 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. Receives: Device: 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 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. Receives: Device: fNIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Within 1 week before the first training session, and within 1 week after the last training session
Secondary outcomes (10)
Go/No-go(post; RT)
Change in Go/No-go mean reaction time
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 1 week before the first training session, and within 1 week after the last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- HOME Psychological Services Ltd., ANT Asia Pacific
- Responsible party
- Principal investigator, YEUNG Kin Chung Michael, Education University of Hong Kong
- Investigators
- Kin Chung Michael Yeung, PhD, Principal investigator, Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149974
- Sponsor's protocol ID
- 2022-2023-0505
- Other IDs
- ITS/077/22
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31302517Van 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.
PubMed 29445867Trambaiolli 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.
PubMed 33587957The 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.
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.
PubMed 32093790Shaffer RC, Pedapati EV, Shic F, Gaietto K, Bowers K, Wink LK, Erickson CA. Brief Report: Diminished Gaze Preference for Dynamic Social Interaction Scenes in Youth with Autism Spectrum Disorders. J Autism Dev Disord. 2017 Feb;47(2):506-513. doi: 10.1007/s10803-016-2975-2.
PubMed 27878742Russo, 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.
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.
PubMed 35714757Pineda JA, Carrasco K, Datko M, Pillen S, Schalles M. Neurofeedback training produces normalization in behavioural and electrophysiological measures of high-functioning autism. Philos Trans R Soc Lond B Biol Sci. 2014 Apr 28;369(1644):20130183. doi: 10.1098/rstb.2013.0183. Print 2014.
PubMed 24778378Pineda, 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.
Perihan C, Burke M, Bowman-Perrott L, Bicer A, Gallup J, Thompson J, Sallese M. Effects of Cognitive Behavioral Therapy for Reducing Anxiety in Children with High Functioning ASD: A Systematic Review and Meta-Analysis. J Autism Dev Disord. 2020 Jun;50(6):1958-1972. doi: 10.1007/s10803-019-03949-7.
PubMed 30810842Mehler DMA, Sokunbi MO, Habes I, Barawi K, Subramanian L, Range M, Evans J, Hood K, Luhrs M, Keedwell P, Goebel R, Linden DEJ. Targeting the affective brain-a randomized controlled trial of real-time fMRI neurofeedback in patients with depression. Neuropsychopharmacology. 2018 Dec;43(13):2578-2585. doi: 10.1038/s41386-018-0126-5. Epub 2018 Jun 23.
PubMed 29967368Marzbani H, Marateb HR, Mansourian M. Neurofeedback: A Comprehensive Review on System Design, Methodology and Clinical Applications. Basic Clin Neurosci. 2016 Apr;7(2):143-58. doi: 10.15412/J.BCN.03070208.
PubMed 27303609Marx AM, Ehlis AC, Furdea A, Holtmann M, Banaschewski T, Brandeis D, Rothenberger A, Gevensleben H, Freitag CM, Fuchsenberger Y, Fallgatter AJ, Strehl U. Near-infrared spectroscopy (NIRS) neurofeedback as a treatment for children with attention deficit hyperactivity disorder (ADHD)-a pilot study. Front Hum Neurosci. 2015 Jan 7;8:1038. doi: 10.3389/fnhum.2014.01038. eCollection 2014.
PubMed 25610390Llorente AM, Voigt RG, Williams J, Frailey JK, Satz P, D'Elia LF. Children's Color Trails Test 1 & 2: test-retest reliability and factorial validity. Clin Neuropsychol. 2009 May;23(4):645-60. doi: 10.1080/13854040802427795. Epub 2008 Oct 21.
PubMed 18942031
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an EEG-fNIRS Neurofeedback Application for Brain Training for Autistic Children
- ClinicalTrials.gov ID
- NCT07149974
- Acronym / sponsor ID
- 2022-2023-0505
- Conditions
- Autism, Autistic Disorders Spectrum, Neurofeedback, EEG, fNIRS
- Keywords
- ASD, Autistic, Neurofeedback, EEG, fNIRS
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Collaborators
- HOME Psychological Services Ltd., ANT Asia Pacific
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does combined EEG-fNIRS neurofeedback improve attention, emotion regulation, and social skills in children with ASD?
- Is this type of neurofeedback training feasible and well-tolerated by children? Researchers will compare the new combined EEG-fNIRS training with single EEG or fNIRS training to see if it provides additional benefits.
Participants will:
.Receive sessions of EEG-fNIRS neurofeedback training. .Complete assessments of thinking skills, emotional regulation, and social functioning before and after training.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Combined EEG-fNIRS group | Experimental | Device: EEG and fNIRSThe 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 | Device: EEGThe 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. |
| fNIRS group | Experimental | Device: fNIRSThe 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 8 to 12 years
- Previous diagnosis of autism spectrum disorder (ASD) or Asperger's syndrome
- No intellectual impairment or studying in mainstream schools
- Right-handedness
- Normal or corrected-to-normal vision
Key exclusion criteria (1 listed)
- Not meeting any of the above inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG and fNIRSFor 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. | Device | Combined EEG-fNIRS group |
| EEGEEG 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). | Device | EEG group |
| fNIRSfNIRS 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. | Device | fNIRS group |
Primary outcome
Effectiveness of treatments for autistic individuals
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
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.
Social behavior and Social impairments
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
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.
Executive function in children and adolescents
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
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.
Anxiety and depression symptoms in children and adolescents
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
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.
10 secondary outcomes
Go/No-go(post; RT)
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
Go/No-go (post; Accuracy)
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
Sternberg Working Memory Task (post; RT)
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
Sternberg Working Memory Task (post; Accuracy)
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
Task Switching (post; RT)
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
Task Switching (post; Accuracy)
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
Child Eyes Test (post; RT)
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
Child Eyes Test (post; Accuracy)
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
Facial Emotion Recognition Task (post; RT)
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
Facial Emotion Recognition Task (post; Accuracy)
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 31302517Wang 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.
- Results publication: PubMed 29445867Van 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.
- Results publication: PubMed 33587957Trambaiolli 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.
- Results publicationThe 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.
- Results publication: PubMed 32093790Steingrimsson 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.
- Results publication: PubMed 27878742Shaffer RC, Pedapati EV, Shic F, Gaietto K, Bowers K, Wink LK, Erickson CA. Brief Report: Diminished Gaze Preference for Dynamic Social Interaction Scenes in Youth with Autism Spectrum Disorders. J Autism Dev Disord. 2017 Feb;47(2):506-513. doi: 10.1007/s10803-016-2975-2.
- Results publicationRusso, 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.
- Results publication: PubMed 35714757Rosson 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.
- Results publication: PubMed 24778378Pineda JA, Carrasco K, Datko M, Pillen S, Schalles M. Neurofeedback training produces normalization in behavioural and electrophysiological measures of high-functioning autism. Philos Trans R Soc Lond B Biol Sci. 2014 Apr 28;369(1644):20130183. doi: 10.1098/rstb.2013.0183. Print 2014.
- Results publicationPineda, 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.
- Results publication: PubMed 30810842Perihan C, Burke M, Bowman-Perrott L, Bicer A, Gallup J, Thompson J, Sallese M. Effects of Cognitive Behavioral Therapy for Reducing Anxiety in Children with High Functioning ASD: A Systematic Review and Meta-Analysis. J Autism Dev Disord. 2020 Jun;50(6):1958-1972. doi: 10.1007/s10803-019-03949-7.
- Results publication: PubMed 29967368Mehler DMA, Sokunbi MO, Habes I, Barawi K, Subramanian L, Range M, Evans J, Hood K, Luhrs M, Keedwell P, Goebel R, Linden DEJ. Targeting the affective brain-a randomized controlled trial of real-time fMRI neurofeedback in patients with depression. Neuropsychopharmacology. 2018 Dec;43(13):2578-2585. doi: 10.1038/s41386-018-0126-5. Epub 2018 Jun 23.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kin Chung Michael Yeung, PhD principal investigator
Education University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG and fNIRS, EEG and fNIRS in people with Autism and Autistic Disorders Spectrum, run by Education University of Hong Kong 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 5 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 8 Sep 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of treatments for autistic individuals (time frame: Within 1 week before the first training session, and within 1 week after the last training session). The study lists 4 primary outcomes in all. 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 NCT07149974, which also lists 33 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 8 Sep 2025.