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NCT Number: NCT07149974

Neurofeedback 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:

* 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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Education And Human Development OF The Educational University Of Hong Kong

Hong Kong, 000000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Not meeting any of the above inclusion criteria

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Go/No-go(post; RT)

    Time frame: Within 1 week before the first training session, and within 1 week after the last training session

    Change in Go/No-go mean reaction time

  2. Go/No-go (post; Accuracy)

    Time frame: Within 1 week before the first training session, and within 1 week after the last training session

    Change in Go/No-go accuracy

  3. 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

    Change in Sternberg task mean reaction time

  4. 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

    Change in Sternberg task accuracy

  5. Task Switching (post; RT)

    Time frame: Within 1 week before the first training session, and within 1 week after the last training session

    Change in Task Switching mean reaction time

  6. Task Switching (post; Accuracy)

    Time frame: Within 1 week before the first training session, and within 1 week after the last training session

    Change in Task Switching accuracy

  7. Child Eyes Test (post; RT)

    Time frame: Within 1 week before the first training session, and within 1 week after the last training session

    Change in Child Eyes Test mean reaction time

  8. Child Eyes Test (post; Accuracy)

    Time frame: Within 1 week before the first training session, and within 1 week after the last training session

    Change in Child Eyes Test accuracy

  9. 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

    Change in Facial Emotion Recognition mean reaction time

  10. 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

    Change in Facial Emotion Recognition accuracy

Sponsors and collaborators

Lead sponsor

Education University of Hong Kong

Other

Collaborators

  • ANT Asia Pacific
  • HOME Psychological Services Ltd.

Registry information

Official study title

Developing an EEG-fNIRS Neurofeedback Application for Brain Training for Autistic Children

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 2, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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