An interventional study of EEG and fNIRS and EEG in Autism, Autistic Disorders Spectrum and Neurofeedback, sponsored by Education University of Hong Kong. Enrolling by invitation at 1 site in Hong Kong. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Education University of Hong Kong · Not applicable, Interventional, and Treatment
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.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 30 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Education University of Hong Kong is the lead sponsor of 35 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
- Not meeting any of the above inclusion criteria
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.
Device: EEG and fNIRS
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.
Device: EEG
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.
Device: fNIRS
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
Go/No-go(post; RT)
Change in Go/No-go mean reaction time
Time frame: 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
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)
Change in Sternberg task mean reaction time
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)
Change in Sternberg task accuracy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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)
Change in Facial Emotion Recognition mean reaction time
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)
Change in Facial Emotion Recognition accuracy
Time frame: Within 1 week before the first training session, and within 1 week after the last training session
Plan to share: 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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