Skip to content

Neurofeedback Training for Autistic Children

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07149974
Enrollment
30
Registered
2025-09-02
Start date
2025-07-01
Completion date
2026-01-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Autistic Disorders Spectrum, EEG, fNIRS, Neurofeedback

Keywords

ASD, Autistic, Neurofeedback, EEG, fNIRS

Brief 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). 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.

Interventions

DEVICEEEG and 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.

DEVICEEEG

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).

DEVICEfNIRS

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.

Sponsors

HOME Psychological Services Ltd.
CollaboratorUNKNOWN
ANT Asia Pacific
CollaboratorUNKNOWN
Education University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of treatments for autistic individualsWithin 1 week before the first training session, and within 1 week after the last training sessionThe 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 impairmentsWithin 1 week before the first training session, and within 1 week after the last training sessionThe 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 adolescentsWithin 1 week before the first training session, and within 1 week after the last training sessionThe 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 adolescentsWithin 1 week before the first training session, and within 1 week after the last training sessionThe 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

MeasureTime frameDescription
Task Switching (post; RT)Within 1 week before the first training session, and within 1 week after the last training sessionChange in Task Switching mean reaction time
Task Switching (post; Accuracy)Within 1 week before the first training session, and within 1 week after the last training sessionChange in Task Switching accuracy
Child Eyes Test (post; RT)Within 1 week before the first training session, and within 1 week after the last training sessionChange in Child Eyes Test mean reaction time
Go/No-go(post; RT)Within 1 week before the first training session, and within 1 week after the last training sessionChange in Go/No-go mean reaction time
Facial Emotion Recognition Task (post; RT)Within 1 week before the first training session, and within 1 week after the last training sessionChange in Facial Emotion Recognition mean reaction time
Facial Emotion Recognition Task (post; Accuracy)Within 1 week before the first training session, and within 1 week after the last training sessionChange in Facial Emotion Recognition accuracy
Child Eyes Test (post; Accuracy)Within 1 week before the first training session, and within 1 week after the last training sessionChange in Child Eyes Test accuracy
Go/No-go (post; Accuracy)Within 1 week before the first training session, and within 1 week after the last training sessionChange in Go/No-go accuracy
Sternberg Working Memory Task (post; RT)Within 1 week before the first training session, and within 1 week after the last training sessionChange in Sternberg task mean reaction time
Sternberg Working Memory Task (post; Accuracy)Within 1 week before the first training session, and within 1 week after the last training sessionChange in Sternberg task accuracy

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026