fNIRS Neurofeedback Training Using Virtual Reality in Children With ADHD

NCT05906485 | Recruiting

• 1 other identifier: EA200247
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ADHD

Keywords

fNIRS Neurofeedback Training; Virtual Reality; Children with ADHD

Outcome Measures

Primary Outcomes (16)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (6)

• Children's ADHD symptoms

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

• Children's ADHD symptoms

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

• Children's ADHD symptoms

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

• Behavioural ratings on children's executive functions

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

• Behavioural ratings on children's executive functions

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

Other Outcomes (2)

• Children's enjoyment of the training

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

• Feasibility of conducting VR training within children

  Up to 8 to 10 weeks (within the intervention period)

Study Arms (3)

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.

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.

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.

Behavioral: fNIRS Neurofeedback-VR Training; Behavioral: Computerized Cognitive Training

Interventions

fNIRS Neurofeedback-VR Training BEHAVIORAL

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

Experimental Group: fNIRS Neurofeedback-VR Training Group; Waitlist Control Group

Computerized Cognitive Training BEHAVIORAL

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

Active Control Group: Computerized Cognitive Training Group; Waitlist Control Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 39645257 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kathy Kar Man SHUM, Dr.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Tsam Ling KEI

CONTACT

+852 6939 4425; hkuadhdvr@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly allocated into groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 18, 2023
• Study Start: June 1, 2023
• Primary Completion: January 11, 2026
• Study Completion: January 11, 2026
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning immediately after publication and ending 5 years after publication.
• Access Criteria: To gain access, requestors will need to provide a clear research aim or methodological sound research plan directed to the principal investigator (kkmshum@hku.hk).

Locations

HK (1)