Neurofeedback Training for Autistic Children

NCT07149974 | Enrolling By Invitation

• 2 other identifiers: 2022-2023-0505ITS/077/22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Autistic Disorders Spectrum; Neurofeedback; EEG; fNIRS

Keywords

ASD; Autistic; Neurofeedback; EEG; fNIRS

Outcome Measures

Primary Outcomes (4)

• 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

  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

Secondary Outcomes (10)

• Go/No-go(post; RT)

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

• Go/No-go (post; Accuracy)

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

• Sternberg Working Memory Task (post; RT)

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

• Sternberg Working Memory Task (post; Accuracy)

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

• Task Switching (post; RT)

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

Study Arms (3)

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.

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.

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.

Device: fNIRS

Interventions

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.

Combined EEG-fNIRS group

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).

EEG group

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.

fNIRS group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Education University of Hong Kong: lead
• HOME Psychological Services Ltd.: collaborator
• ANT Asia Pacific: collaborator

Study Sites (1)

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

Hong Kong, Hong Kong, 000000, Hong Kong

Location

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  BACKGROUND

MeSH Terms

Conditions

Autistic Disorder; Child Development Disorders, Pervasive

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Kin Chung Michael Yeung, PhD

  Education University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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).

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)