Attention Deficit Disorder With Hyperactivity (ADHD)VR-fNIRS-RCT2NCT06743763
fNIRS-Based Neurofeedback Training in Children With ADHD: The Effects of VR
A study testing fNIRS-based neurofeedback and Virtual Reality Simulated Classroom in people with Attention Deficit Disorder With Hyperactivity (ADHD), run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity (ADHD)
- What is being tested?
- fNIRS-based neurofeedback and Virtual Reality Simulated Classroom
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2024to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7- 12
- Clinical diagnosis of ADHD
- Significant teacher- or parent-reported attention problems during screening
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of fNIRS-Based Neurofeedback Training in Children With ADHD: The Impact of Virtual Reality Integration
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:
Read more
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.
- Being tested
- fNIRS-based neurofeedback, Virtual Reality Simulated Classroom
- Keywords
- neurofeedback, fNIRS, ADHD, children, virtual reality
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fNIRS-based neurofeedbackBehavioural
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 ClassroomBehavioural
A simulated classroom scenario is integrated in VR setting and children are asked to complete academic tasks in the simulated classroom.
| Study group | Role | What they receive |
|---|---|---|
| fNIRS-NFT with VR | Experimental | The experimental group will receive 16 sessions of training, 1 hour each, conducted twice per week over a period of 8 weeks. A classroom setting will be stimulated using VR and participants will be asked to complete some academic-related tasks during the stimulated lessons. The sensor on the neurofeedback device worn by the participants will detect changes in the blood oxy-hemoglobin level in brain cortical tissue and feedback to the participants via visual images or auditory sounds from the computer. Through practice, participants will learn to manipulate their attention, presumably by altering brain activities. Receives: Behavioral: fNIRS-based neurofeedback; Behavioral: Virtual Reality Simulated Classroom |
| fNIRS-NFT without VR | Active comparator | The fNIRS-NFT without VR (NFT-2D group) will receive 16 sessions of training, 1 hour each, conducted twice per week over a period of 8 weeks. A classroom setting will be stimulated via a computer screen and participants will be asked to complete some academic-related tasks during the stimulated lessons by pressing a remote controller provided. The sensor on the neurofeedback device worn by the participants will detect changes in the blood oxy-hemoglobin level in brain cortical tissue and feedback to the participants via visual images or auditory sounds from the computer. Through practice, participants hopefully will learn to manipulate their attention, presumably by altering brain activities. Receives: Behavioral: fNIRS-based neurofeedback |
| VR without fNIRS-NFT | Active comparator | In the VR without fNIRS-NFT Training, we have designed a virtual reality classroom scenario modeled and children are asked to complete academic tasks in the VR setting but no neurofeedback will be provided. Receives: Behavioral: Virtual Reality Simulated Classroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's ADHD symptoms
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.
Measured: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Children's ADHD symptoms
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.
Measured: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Children's ADHD symptoms
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.
Measured: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Secondary outcomes (12)
Conners Continuous Performance Test 3rd Edition (CPT 3)
A standardized computerized test on sustained attention and inhibitory control
Measured: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Conners Continuous Performance Test 3rd Edition (CPT 3)
A standardized computerized test on sustained attention and inhibitory control
Measured: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Conners Continuous Performance Test 3rd Edition (CPT 3)
A standardized computerized test on sustained attention and inhibitory control
Measured: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Functional NIRS
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.
Measured: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Functional NIRS
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.
Measured: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Functional NIRS
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.
Measured: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Number subtest of Children's Memory Scale (CMS)
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.
Measured: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Number subtest of Children's Memory Scale (CMS)
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.
Measured: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Number subtest of Children's Memory Scale (CMS)
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.
Measured: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Behavioural ratings on children's executive functions
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
Measured: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Behavioural ratings on children's executive functions
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
Measured: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Behavioural ratings on children's executive functions
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
Measured: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Dec 2024
- Primary completion17 Apr 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With Hyperactivity (ADHD)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: receives 8-week functional near-infrared spectroscopy (fNIRS) neurofeedback training (coupled with virtual reality), twice per week, each lasting 1 hour. Comparative group 1: receives 8-week functional near-infrared spectroscopy (fNIRS) neurofeedback training without virtual reality(VR) technology, twice per week, each lasting 1 hour. Comparative group 2: receives 8-week training using VR technology (without neurofeedback) twice per week, each lasting 1 hour.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kathy Shum, The University of Hong Kong
- Investigators
- Kar-man Kathy Shum, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743763
- Sponsor's protocol ID
- EA200247(RCT2)
- Acronym
- VR-fNIRS-RCT2
- Status last verified
- Aug 2026
- First submitted
- 16 Dec 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified individual participant data collected during the trial will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of fNIRS-Based Neurofeedback Training in Children With ADHD: The Impact of Virtual Reality Integration
- ClinicalTrials.gov ID
- NCT06743763
- Acronym / sponsor ID
- VR-fNIRS-RCT2 / EA200247(RCT2)
- Keywords
- neurofeedback, fNIRS, ADHD, children, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Experimental group: receives 8-week functional near-infrared spectroscopy (fNIRS) neurofeedback training (coupled with virtual reality), twice per week, each lasting 1 hour. Comparative group 1: receives 8-week functional near-infrared spectroscopy (fNIRS) neurofeedback training without virtual reality(VR) technology, twice per week, each lasting 1 hour. Comparative group 2: receives 8-week training using VR technology (without neurofeedback) twice per week, each lasting 1 hour.
| Arm | Type | Receives |
|---|---|---|
| fNIRS-NFT with VR | Experimental | Behavioral: fNIRS-based neurofeedback, Behavioral: Virtual Reality Simulated ClassroomThe experimental group will receive 16 sessions of training, 1 hour each, conducted twice per week over a period of 8 weeks. A classroom setting will be stimulated using VR and participants will be asked to complete some academic-related tasks during the stimulated lessons. The sensor on the neurofeedback device worn by the participants will detect changes in the blood oxy-hemoglobin level in brain cortical tissue and feedback to the participants via visual images or auditory sounds from the computer. Through practice, participants will learn to manipulate their attention, presumably by altering brain activities. |
| fNIRS-NFT without VR | Active comparator | Behavioral: fNIRS-based neurofeedbackThe fNIRS-NFT without VR (NFT-2D group) will receive 16 sessions of training, 1 hour each, conducted twice per week over a period of 8 weeks. A classroom setting will be stimulated via a computer screen and participants will be asked to complete some academic-related tasks during the stimulated lessons by pressing a remote controller provided. The sensor on the neurofeedback device worn by the participants will detect changes in the blood oxy-hemoglobin level in brain cortical tissue and feedback to the participants via visual images or auditory sounds from the computer. Through practice, participants hopefully will learn to manipulate their attention, presumably by altering brain activities. |
| VR without fNIRS-NFT | Active comparator | Behavioral: Virtual Reality Simulated ClassroomIn the VR without fNIRS-NFT Training, we have designed a virtual reality classroom scenario modeled and children are asked to complete academic tasks in the VR setting but no neurofeedback will be provided. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 7- 12
- Clinical diagnosis of ADHD
- Significant teacher- or parent-reported attention problems during screening
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fNIRS-based neurofeedbackfNIRS-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. | Behavioural | fNIRS-NFT with VR, fNIRS-NFT without VR |
| Virtual Reality Simulated ClassroomA simulated classroom scenario is integrated in VR setting and children are asked to complete academic tasks in the simulated classroom. | Behavioural | VR without fNIRS-NFT, fNIRS-NFT with VR |
Primary outcome
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.
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.
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.
12 secondary outcomes
Conners Continuous Performance Test 3rd Edition (CPT 3)
Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Conners Continuous Performance Test 3rd Edition (CPT 3)
Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
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)
Functional NIRS
Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Functional NIRS
Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Functional NIRS
Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Number subtest of Children's Memory Scale (CMS)
Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Number subtest of Children's Memory Scale (CMS)
Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
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)
Behavioural ratings on children's executive functions
Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Behavioural ratings on children's executive functions
Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Behavioural ratings on children's executive functions
Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. The de-identified individual participant data collected during the trial will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kar-man Kathy Shum, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fNIRS-based neurofeedback and Virtual Reality Simulated Classroom in people with Attention Deficit Disorder With Hyperactivity (ADHD), run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's ADHD symptoms (time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.