fNIRS Neurofeedback Training Using Virtual Reality in Children With ADHD

ADHD Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906485
• Other study ID #: EA200247
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: January 11, 2026

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: Kathy Tsam Ling KEI
• Phone: +852 6939 4425
• Email: hkuadhdvr[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: January 11, 2026
• Est. primary completion date: January 11, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Behavioral:
• fNIRS Neurofeedback-VR Training
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
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.

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Children's enjoyment of the training	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.	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Other	Feasibility of conducting VR training within children	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.	Up to 8 to 10 weeks (within the intervention period)
Primary	Conners Continuous Performance Test 3rd Edition (CPT 3)	A standardized computerized test on sustained attention and inhibitory control	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Primary	Conners Continuous Performance Test 3rd Edition (CPT 3)	A standardized computerized test on sustained attention and inhibitory control	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Primary	Conners Continuous Performance Test 3rd Edition (CPT 3)	A standardized computerized test on sustained attention and inhibitory control	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Primary	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.	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Primary	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.	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Primary	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.	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Primary	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.	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Primary	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.	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Primary	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.	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Primary	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.	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Primary	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.	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Primary	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.	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Primary	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.	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Primary	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.	Up to 8 to 10 weeks (within the intervention period)
Primary	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.	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Primary	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.	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Secondary	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.	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Secondary	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.	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Secondary	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.	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Secondary	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	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Secondary	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	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Secondary	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	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)