Clinical trial NCT05906485: fNIRS Neurofeedback Training Using Virtual Reality in Children With ADHD
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Keywords: fNIRS Neurofeedback Training
Virtual Reality
Children with ADHD
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 138
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Conners Continuous Performance Test 3rd Edition (CPT 3)
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
measure: Conners Continuous Performance Test 3rd Edition (CPT 3)
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Conners Continuous Performance Test 3rd Edition (CPT 3)
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Number subtest of Children's Memory Scale (CMS)
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
measure: Number subtest of Children's Memory Scale (CMS)
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Number subtest of Children's Memory Scale (CMS)
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
measure: Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
measure: Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Functional NIRS
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
measure: Functional NIRS
timeFrame: Up to 8 to 10 weeks (within the intervention period)
measure: Functional NIRS
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Functional NIRS
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Secondary outcomes:
measure: Children's ADHD symptoms
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
measure: Children's ADHD symptoms
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Children's ADHD symptoms
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Behavioural ratings on children's executive functions
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
measure: Behavioural ratings on children's executive functions
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Behavioural ratings on children's executive functions
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Other outcomes:
measure: Children's enjoyment of the training
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Feasibility of conducting VR training within children
timeFrame: Up to 8 to 10 weeks (within the intervention period)
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Kathy Kar Man SHUM, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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