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Completed

NCT Number: NCT05906485

fNIRS Neurofeedback Training Using Virtual Reality in Children With ADHD

The study aims to explore the effectiveness of neurofeedback training on improving attention and inhibitory control of children with attention-deficit/hyperactivity disorder (ADHD) in Hong Kong. This study will contribute to the current understanding of the alternative treatments for ADHD, and hopefully help to mobilize more resources to support children with ADHD. The programme includes the following components:

Participants will be randomly assigned to the neurofeedback training group (with virtual reality [VR] technology applied), the computerized cognitive training group, or the waitlist control group. All participants will complete a total of 16 training sessions in 8 weeks (twice a week), and each session will last around 35 to 60 mins.

To investigate the intervention effectiveness, children will be asked to complete a set of cognitive tests covering inhibitory control, attention, and working memory prior to the intervention (i.e., Time 1), immediately after the 8-week training (i.e., Time 2), and 2 months after the training (i.e., Time 3, a 2-month follow up). The assessment will take around 1 hour and it will be conducted at the laboratory at the University of Hong Kong. Also, parents and teachers will be asked to complete a questionnaire assessing children's behaviours at home and schools at 3 timepoints.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children aged 7- 12
  • Clinical diagnosis of ADHD
  • Significant teacher- or parent-reported attention problems during screening

Exclusion criteria

  • IQ under 70, as measured on Raven's Progressive Matrices
  • Hearing, visual, or physical impairments that might hinder participation in the training and assessment activities
  • Clinical diagnosis and suspected cases of Autism Spectrum Disorder (ASD)
  • Prior or current participation in NFT
  • Current participation in a psychotherapeutic treatment

Treatment and study plan

fNIRS Neurofeedback-VR Training

Behavioral

In the fNIRS Neurofeedback-VR Training, we have designed a classroom scenario modeled and children are expected to learn how to regulate their attention based on the feedback provided by the fNIRS on the oxygenated haemoglobin level in their prefrontal cortex.

Computerized cognitive training

Behavioral

In the Computerized Cognitive Training, children will complete a range of tasks covering attention control and working memory using a conventional training programme, namely Cogmed.

Primary outcomes

  1. Conners Continuous Performance Test 3rd Edition (CPT 3)

    Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)

    A standardized computerized test on sustained attention and inhibitory control

  2. Conners Continuous Performance Test 3rd Edition (CPT 3)

    Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)

    A standardized computerized test on sustained attention and inhibitory control

  3. Conners Continuous Performance Test 3rd Edition (CPT 3)

    Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)

    A standardized computerized test on sustained attention and inhibitory control

  4. Number subtest of Children's Memory Scale (CMS)

    Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)

    A verbal working memory test using digit span, with a higher score indicating a higher level of verbal working memory. The total score of this test ranges from 0 to 30.

  5. Number subtest of Children's Memory Scale (CMS)

    Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)

    A verbal working memory test using digit span, with a higher score indicating a higher level of verbal working memory. The total score of this test ranges from 0 to 30.

  6. Number subtest of Children's Memory Scale (CMS)

    Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)

    A verbal working memory test using digit span, with a higher score indicating a higher level of verbal working memory. The total score of this test ranges from 0 to 30.

  7. Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)

    Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)

    A measure of attentional control/switching that requires the child to make cognitive reversals.

  8. Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)

    Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)

    A measure of attentional control/switching that requires the child to make cognitive reversals.

  9. Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)

    Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)

    A measure of attentional control/switching that requires the child to make cognitive reversals.

  10. Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)

    Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)

    A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward.

  11. Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)

    Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)

    A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward.

  12. Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)

    Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)

    A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward.

  13. Functional NIRS

    Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)

    The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured throughout the training sessions and direct assessments using functional NIRS.

  14. Functional NIRS

    Time frame: Up to 8 to 10 weeks (within the intervention period)

    The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured throughout the training sessions and direct assessments using functional NIRS.

  15. Functional NIRS

    Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)

    The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured throughout the training sessions and direct assessments using functional NIRS.

  16. Functional NIRS

    Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)

    The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured throughout the training sessions and direct assessments using functional NIRS.

Secondary outcomes

  1. Children's ADHD symptoms

    Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)

    Parents and teachers will be asked to complete the Swanson, Nolan, and Pelham Version IV Scale (SNAP-IV) measuring children's inattentive, hyperactive and impulsive symptoms with a 4-point Likert scale (ranges from 0 to 3). The minimum total score is 0 while the maximum total score is 78, with a higher score indicating a higher level of inattentive, hyperactive and impulsive symptoms.

  2. Children's ADHD symptoms

    Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)

    Parents and teachers will be asked to complete the Swanson, Nolan, and Pelham Version IV Scale (SNAP-IV) measuring children's inattentive, hyperactive and impulsive symptoms with a 4-point Likert scale (ranges from 0 to 3). The minimum total score is 0 while the maximum total score is 78, with a higher score indicating a higher level of inattentive, hyperactive and impulsive symptoms.

  3. Children's ADHD symptoms

    Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)

    Parents and teachers will be asked to complete the Swanson, Nolan, and Pelham Version IV Scale (SNAP-IV) measuring children's inattentive, hyperactive and impulsive symptoms with a 4-point Likert scale (ranges from 0 to 3). The minimum total score is 0 while the maximum total score is 78, with a higher score indicating a higher level of inattentive, hyperactive and impulsive symptoms.

  4. Behavioural ratings on children's executive functions

    Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)

    Parents and teachers will be asked to complete Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including behavioural, emotional and cognitive regulation

  5. Behavioural ratings on children's executive functions

    Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)

    Parents and teachers will be asked to complete Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including behavioural, emotional and cognitive regulation

  6. Behavioural ratings on children's executive functions

    Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)

    Parents and teachers will be asked to complete Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including behavioural, emotional and cognitive regulation

Other outcomes

  1. Children's enjoyment of the training

    Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)

    Children's enjoyment of the training will be evaluated using the Cognitive Absorption Scale (CAS) using a 7-point Likert scale (ranges from 1 to 7), which includes four dimensions: temporal dissociation, focused immersion, heightened enjoyment, and curiosity. The total score of this scale ranges from 7 to 119, with a higher score indicating a higher level of children's enjoyment of the training.

  2. Feasibility of conducting VR training within children

    Time frame: Up to 8 to 10 weeks (within the intervention period)

    Children's symptoms of cybersickness (e.g., nausea, fatigue, eye strain) will be measured using the Simulator Sickness Questionnaire (SSQ) after completing every training session, using a 4-point Likert scale (ranges from 0 to 3). The minimum weighted total score of this scale is 0 and the maximum weighted total score is 235.62, with a higher score indicating a higher level of symptoms of cybersickness.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Randomized Controlled Trials of the Effects of Near-infrared Spectroscopy (fNIRS) Neurofeedback Training Coupled With Virtual Reality Technology in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Apr 7, 2026

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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