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fNIRS Neurofeedback Training Using Virtual Reality in Children With ADHD

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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05906485
Enrollment
138
Registered
2023-06-18
Start date
2023-06-10
Completion date
2024-12-23
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

fNIRS Neurofeedback Training, Virtual Reality, Children with ADHD

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.

Interventions

BEHAVIORALfNIRS 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.

BEHAVIORALComputerized 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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants will be randomly allocated into groups.

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Conners Continuous Performance Test 3rd Edition (CPT 3)Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)A standardized computerized test on sustained attention and inhibitory control
Number subtest of Children's Memory Scale (CMS)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.
Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)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.
Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)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.
Functional NIRSPre-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.

Secondary

MeasureTime frameDescription
Children's ADHD symptomsPre-intervention Assessment (within 4 weeks before the commencement of the intervention)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.
Behavioural ratings on children's executive functionsPre-intervention Assessment (within 4 weeks before the commencement of the intervention)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

Countries

Hong Kong

Contacts

PRINCIPAL_INVESTIGATORKathy Kar Man SHUM, Dr.

The University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026