ADHDNCT05906485
fNIRS Neurofeedback Training Using Virtual Reality in Children With ADHD
A study testing fNIRS Neurofeedback-VR Training and Computerized Cognitive Training in people with ADHD, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- fNIRS Neurofeedback-VR Training and Computerized Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Jun 2023to 23 Dec 2024
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
- Conditions
- ADHD
- Being tested
- fNIRS Neurofeedback-VR Training, Computerized Cognitive Training
- Keywords
- fNIRS Neurofeedback Training, Virtual Reality, Children with ADHD
- 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 Neurofeedback-VR TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: fNIRS Neurofeedback-VR Training Group | 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 Neurofeedback-VR Training |
| Active Control Group: Computerized Cognitive Training Group | Active comparator | The computerized cognitive training group will receive 16 sessions of training, 35 minutes each, conducted twice per week over a period of 8 weeks. Participants will be asked to complete a set of computerized tasks using Cogmed, a digital training programme which is proven to enhance working memory and attention level in children. Receives: Behavioral: Computerized Cognitive Training |
| Waitlist Control Group | Other | The waitlist control group will not receive any intervention until the intervention arms complete their training. Depending on the availability, either the fNIRS Neurofeedback-VR Training or the Computerized Cognitive Training will be offered to this group. Receives: Behavioral: fNIRS Neurofeedback-VR Training; Behavioral: Computerized Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)
A measure of attentional control/switching that requires the child to make cognitive reversals.
Measured: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)
A measure of attentional control/switching that requires the child to make cognitive reversals.
Measured: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)
A measure of attentional control/switching that requires the child to make cognitive reversals.
Measured: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)
A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward.
Measured: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)
A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward.
Measured: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)
A measure of attentional control and switching that requires children to repeatedly switch between two simple activities, counting upward and counting downward.
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 throughout the training sessions and direct assessments 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 throughout the training sessions and direct assessments using functional NIRS.
Measured: Up to 8 to 10 weeks (within the intervention period)
Functional NIRS
The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured throughout the training sessions and direct assessments 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 throughout the training sessions and direct assessments using functional NIRS.
Measured: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Secondary outcomes (6)
Children's ADHD symptoms
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.
Measured: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Children's ADHD symptoms
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.
Measured: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Children's ADHD symptoms
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.
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 posted18 Jun 2023
- Study start10 Jun 2023
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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) in Phase 1, twice per week, each lasts 1 hour. Active control group: receives 8-weeks computerized cognitive training in Phase 1, twice per week, each lasts 35 minutes. Waitlist control group: either receives 8-weeks fNIRS neurofeedback training (coupled with virtual reality) or computerized cognitive training in Phase 2 (i.e., after the completion of training for intervention group and active control group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 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
- Kathy Kar Man SHUM, Dr., Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906485
- Sponsor's protocol ID
- EA200247
- Status last verified
- Apr 2026
- First submitted
- 22 May 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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. A study protocol of the current study will be available as well.
Publications
Blume, F., Quixal, M., Hudak, J., Dresler, T., Gawrilow, C., & Ehlis, A. C. (2020). Development of Reading Abilities in Children with ADHD Following fNIRS-Neurofeedback or EMGBiofeedback. Lernen und Lernstörungen, 9(3) 2. Blume, F., Hudak, J., Dresler, T., Ehlis, A. C., Kühnhausen, J., Renner, T. J., & Gawrilow, C. (2017). NIRS-based neurofeedback training in a virtual reality classroom for children with attention-deficit/hyperactivity disorder: study protocol for a randomized controlled trial. Trials, 18(1), 1-16. 3. Marx, A.-M., Ehlis, A.-C., Furdea, A., Holtmann, M., Banaschewski, T., Brandeis, D., … Strehl, U. (2015). Near-infrared spectroscopy (NIRS) neurofeedback as a treatment for children with attention deficit hyperactivity disorder (ADHD): a pilot study. Frontiers in Human Neuroscience, 8(JAN), 1038. 4. Strehl, U., Leins, U., Goth, G., Klinger, C., Hinterberger, T., & Birbaumer, N. (2006). Selfregulation of slow cortical potentials: a new treatment for children with attentiondeficit/hyperactivity disorder. Pediatrics, 118(5), e1530-e1540. 5. Cogmed (2020). Cogmed Working Memory Training. Pearson Clinical Assessment UK. 6. Gau, S. S. F., Lin, C. H., Hu, F. C., Shang, C. Y., Swanson, J. M., Liu, Y. C., & Liu, S. K. (2008). Psychometric properties of the Chinese version of the Swanson, Nolan, and Pelham, version IV scale-Teacher Form. Journal of Pediatric Psychology, 34(8), 850-861. 7. Gau, S. S. F., Shang, C. Y., Liu, S. K., Lin, C. H., Swanson, J. M., Liu, Y. C., & Tu, C. L. (2008). Psychometric properties of the Chinese version of the Swanson, Nolan, and Pelham, version IV scale-parent form. International Journal of Methods in Psychiatric Research, 17(1), 35-44. 8. Gioia, G. A., Isquith, P. K., Guy, S. C., & Kenworthy, L. (2015). BRIEF-2, Behavior Rating Inventory of Executive Function (2nd Ed.). Psychological Assessment Resources, Inc. 9. Shum, K. K. M., Zheng, Q., Chak, G. S., Kei, K. T. L., Lam, C. W. C., Lam, I. K. Y., Lok, C. S. W., & Tang, J. W. Y. (2021). Dimensional structure of the BRIEF2 and its relations with ADHD symptoms and task performance on executive functions in Chinese children. Child Neuropsychology, 27(2), 165-189. 10. Conners, C. K. (2014). Conners Continuous Performance Test 3rd Edition (Conners CPT 3). Multi-Health Systems, Inc. 11. Cohen, M. J. (1997). Children's Memory Scale. The Psychological Corporation. 12. Manly et al. (1998). Test of Everyday Attention for Children. Pearson Clinical Assessment UK. 13. Volpe, R. J., DiPerna, J. C., Hintze, J. M., & Shapiro, E. S. (2005). Observing students in classroom settings: A review of seven coding schemes. School Psychology Review, 34(4), 454-474. 14. Kennedy, R. S., Lane, N. E., Berbaum, K. S., & Lilienthal, M. G. (1993). Simulator sickness questionnaire: An enhanced method for quantifying simulator sickness. The International Journal of Aviation Psychology, 3(3), 203-220. 15. Agarwal, R., & Karahanna, E. (2000). Time flies when you're having fun: Cognitive absorption and beliefs about information technology usage. MIS Quarterly, 24(4), 665-694.
Zheng Q, Kei KT, Chiu KY, Shum KK. Study protocol of a randomised controlled trial of the effects of near-infrared spectroscopy neurofeedback training coupled with virtual reality technology in children with ADHD. BMJ Open. 2024 Dec 7;14(12):e093183. doi: 10.1136/bmjopen-2024-093183.
PubMed 39645257
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05906485
- Acronym / sponsor ID
- EA200247
- Conditions
- ADHD
- Keywords
- fNIRS Neurofeedback Training, Virtual Reality, Children with ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 18 Jun 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Experimental group: receives 8-week functional near-infrared spectroscopy (fNIRS) neurofeedback training (coupled with virtual reality) in Phase 1, twice per week, each lasts 1 hour. Active control group: receives 8-weeks computerized cognitive training in Phase 1, twice per week, each lasts 35 minutes. Waitlist control group: either receives 8-weeks fNIRS neurofeedback training (coupled with virtual reality) or computerized cognitive training in Phase 2 (i.e., after the completion of training for intervention group and active control group).
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: fNIRS Neurofeedback-VR Training Group | Experimental | Behavioral: fNIRS Neurofeedback-VR TrainingThe 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. |
| Active Control Group: Computerized Cognitive Training Group | Active comparator | Behavioral: Computerized Cognitive TrainingThe computerized cognitive training group will receive 16 sessions of training, 35 minutes each, conducted twice per week over a period of 8 weeks. Participants will be asked to complete a set of computerized tasks using Cogmed, a digital training programme which is proven to enhance working memory and attention level in children. |
| Waitlist Control Group | Other | Behavioral: fNIRS Neurofeedback-VR Training, Behavioral: Computerized Cognitive TrainingThe waitlist control group will not receive any intervention until the intervention arms complete their training. Depending on the availability, either the fNIRS Neurofeedback-VR Training or the Computerized Cognitive Training will be offered to this group. |
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)
- 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
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 Neurofeedback-VR TrainingIn 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. | Behavioural | Experimental Group: fNIRS Neurofeedback-VR Training Group, Waitlist Control Group |
| Computerized Cognitive TrainingIn the Computerized Cognitive Training, children will complete a range of tasks covering attention control and working memory using a conventional training programme, namely Cogmed. | Behavioural | Active Control Group: Computerized Cognitive Training Group, Waitlist Control Group |
Primary outcome
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Children's ADHD symptoms
Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Children's ADHD symptoms
Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Children's ADHD symptoms
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 Apr 2026.
- BackgroundBlume, F., Quixal, M., Hudak, J., Dresler, T., Gawrilow, C., & Ehlis, A. C. (2020). Development of Reading Abilities in Children with ADHD Following fNIRS-Neurofeedback or EMGBiofeedback. Lernen und Lernstörungen, 9(3) 2. Blume, F., Hudak, J., Dresler, T., Ehlis, A. C., Kühnhausen, J., Renner, T. J., & Gawrilow, C. (2017). NIRS-based neurofeedback training in a virtual reality classroom for children with attention-deficit/hyperactivity disorder: study protocol for a randomized controlled trial. Trials, 18(1), 1-16. 3. Marx, A.-M., Ehlis, A.-C., Furdea, A., Holtmann, M., Banaschewski, T., Brandeis, D., … Strehl, U. (2015). Near-infrared spectroscopy (NIRS) neurofeedback as a treatment for children with attention deficit hyperactivity disorder (ADHD): a pilot study. Frontiers in Human Neuroscience, 8(JAN), 1038. 4. Strehl, U., Leins, U., Goth, G., Klinger, C., Hinterberger, T., & Birbaumer, N. (2006). Selfregulation of slow cortical potentials: a new treatment for children with attentiondeficit/hyperactivity disorder. Pediatrics, 118(5), e1530-e1540. 5. Cogmed (2020). Cogmed Working Memory Training. Pearson Clinical Assessment UK. 6. Gau, S. S. F., Lin, C. H., Hu, F. C., Shang, C. Y., Swanson, J. M., Liu, Y. C., & Liu, S. K. (2008). Psychometric properties of the Chinese version of the Swanson, Nolan, and Pelham, version IV scale-Teacher Form. Journal of Pediatric Psychology, 34(8), 850-861. 7. Gau, S. S. F., Shang, C. Y., Liu, S. K., Lin, C. H., Swanson, J. M., Liu, Y. C., & Tu, C. L. (2008). Psychometric properties of the Chinese version of the Swanson, Nolan, and Pelham, version IV scale-parent form. International Journal of Methods in Psychiatric Research, 17(1), 35-44. 8. Gioia, G. A., Isquith, P. K., Guy, S. C., & Kenworthy, L. (2015). BRIEF-2, Behavior Rating Inventory of Executive Function (2nd Ed.). Psychological Assessment Resources, Inc. 9. Shum, K. K. M., Zheng, Q., Chak, G. S., Kei, K. T. L., Lam, C. W. C., Lam, I. K. Y., Lok, C. S. W., & Tang, J. W. Y. (2021). Dimensional structure of the BRIEF2 and its relations with ADHD symptoms and task performance on executive functions in Chinese children. Child Neuropsychology, 27(2), 165-189. 10. Conners, C. K. (2014). Conners Continuous Performance Test 3rd Edition (Conners CPT 3). Multi-Health Systems, Inc. 11. Cohen, M. J. (1997). Children's Memory Scale. The Psychological Corporation. 12. Manly et al. (1998). Test of Everyday Attention for Children. Pearson Clinical Assessment UK. 13. Volpe, R. J., DiPerna, J. C., Hintze, J. M., & Shapiro, E. S. (2005). Observing students in classroom settings: A review of seven coding schemes. School Psychology Review, 34(4), 454-474. 14. Kennedy, R. S., Lane, N. E., Berbaum, K. S., & Lilienthal, M. G. (1993). Simulator sickness questionnaire: An enhanced method for quantifying simulator sickness. The International Journal of Aviation Psychology, 3(3), 203-220. 15. Agarwal, R., & Karahanna, E. (2000). Time flies when you're having fun: Cognitive absorption and beliefs about information technology usage. MIS Quarterly, 24(4), 665-694.
- Derived from this study: PubMed 39645257Zheng Q, Kei KT, Chiu KY, Shum KK. Study protocol of a randomised controlled trial of the effects of near-infrared spectroscopy neurofeedback training coupled with virtual reality technology in children with ADHD. BMJ Open. 2024 Dec 7;14(12):e093183. doi: 10.1136/bmjopen-2024-093183.
- Individual participant dataSharing planned: Yes. The de-identified individual participant data collected during the trial will be available upon reasonable request. A study protocol of the current study will be available as well.
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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.
Kathy Kar Man SHUM, Dr. 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 Neurofeedback-VR Training and Computerized Cognitive Training in people with 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 Apr 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?
Conners Continuous Performance Test 3rd Edition (CPT 3) (time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05906485, which also lists 2 linked publications.
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 Apr 2026.