fNIRS Neurofeedback Training Using Virtual Reality in Children With ADHD

NCT ID: NCT05906485

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-01-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group: fNIRS Neurofeedback-VR Training Group

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.

Group Type: EXPERIMENTAL

fNIRS Neurofeedback-VR Training

Intervention Type: 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.

Active Control Group: Computerized Cognitive Training Group

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.

Group Type: ACTIVE_COMPARATOR

Computerized Cognitive Training

Intervention Type: 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.

Waitlist Control Group

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.

Group Type: OTHER

fNIRS Neurofeedback-VR Training

Intervention Type: 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.

Computerized Cognitive Training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kathy Shum

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathy Kar Man SHUM, Dr.

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

The University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Kathy Tsam Ling KEI

Role: CONTACT

hkuadhdvr@outlook.com

+852 6939 4425

Facility Contacts

Kathy Tsam Ling KEI

Role: primary

hkuadhdvr@outlook.com

+852 6939 4425

References

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.

Reference Type: 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.

Reference Type: DERIVED

PMID: 39645257 (View on PubMed)

Other Identifiers

EA200247

Identifier Type: -

Identifier Source: org_study_id