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NCT Number: NCT06743763

fNIRS-Based Neurofeedback Training in Children With ADHD: The Effects of VR

The study aims to explore whether the treatment using fNIRS-based neurofeedback training for children with attention-deficit/hyperactivity disorder (ADHD) is useful. Furthermore, the study hopes to evaluate whether the use of virtual reality (VR) technology will have an impact on the treatment's effectiveness.

The program includes the following components:

Participants will be randomly assigned to one of three intervention groups: the neurofeedback with virtual reality (VR) group, the 2D neurofeedback group (with no VR technology applied), and the VR without neurofeedback group. All participants will complete academic-related tasks in simulated lessons. Participants in the VR neurofeedback group will wear VR goggles and a neurofeedback device that measures blood oxy-hemoglobin levels in brain cortical tissue and provides feedback via visual images or auditory sounds to the participants. Those in the 2D neurofeedback group will use a computer to complete the tasks, with all other settings (e.g., neurofeedback settings) remaining the same. The VR without neurofeedback group will wear VR goggles to complete tasks, but without the neurofeedback component.

All participants will complete a total of 16 training sessions over 8 weeks (twice a week), with each session lasting approximately 35 to 60 minutes.

To investigate the intervention's effectiveness, children will be asked to complete a set of cognitive tests covering inhibitory control, attention, and working memory before 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 will be conducted at the laboratory at the University of Hong Kong. Additionally, parents and teachers will be asked to complete a questionnaire assessing children's behavior at home and at school at three time points.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Attention Deficit Disorder With Hyperactivity (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

  • Inability to answer the first five questions in 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-based neurofeedback

Behavioral

fNIRS-based neurofeedback is provided during a simulated classroom scenario where the child participants are asked to learn to regulate their attention based on the feedback provided by the fNIRS on the oxygenated haemoglobin level in their prefrontal cortex.

Virtual Reality Simulated Classroom

Behavioral

A simulated classroom scenario is integrated in VR setting and children are asked to complete academic tasks in the simulated classroom.

Primary outcomes

  1. Children's ADHD symptoms

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

    Parents 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 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 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.

Secondary 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. 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 during the direct assessment task of Conners Continuous Performance Test 3rd Edition (CPT3) using functional NIRS.

  5. 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 during the direct assessment task of Conners Continuous Performance Test 3rd Edition (CPT3) using functional NIRS.

  6. 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 during the direct assessment task of Conners Continuous Performance Test 3rd Edition (CPT3) using functional NIRS.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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

Comparative Effectiveness of fNIRS-Based Neurofeedback Training in Children With ADHD: The Impact of Virtual Reality Integration

Acronym: VR-fNIRS-RCT2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2024
Registry last updated
May 1, 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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