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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Conners Continuous Performance Test 3rd Edition (CPT 3)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants will be randomly allocated into groups.
Eligibility Criteria
- Ages
- 7 Years to 12 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: fNIRS Neurofeedback-VR Training (Behavioral)
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.
Intervention: Computerized Cognitive Training (Behavioral)
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.
Intervention: fNIRS Neurofeedback-VR Training (Behavioral)
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.
Intervention: Computerized Cognitive Training (Behavioral)
Outcomes
Primary Outcomes
Conners Continuous Performance Test 3rd Edition (CPT 3)
Time Frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
A standardized computerized test on sustained attention and inhibitory control
Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)
Time Frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion 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.
Number subtest of Children's Memory Scale (CMS)
Time Frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion 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)
Time Frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
A measure of attentional control/switching that requires the child to make cognitive reversals.
Functional NIRS
Time Frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion 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.
Conners Continuous Performance Test 3rd Edition (CPT 3)
Time Frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
A standardized computerized test on sustained attention and inhibitory control
Conners Continuous Performance Test 3rd Edition (CPT 3)
Time Frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
A standardized computerized test on sustained attention and inhibitory control
Number subtest of Children's Memory Scale (CMS)
Time Frame: 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.
Number subtest of Children's Memory Scale (CMS)
Time Frame: Immediate Post-intervention Assessment (within 4 weeks after the completion 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)
Time Frame: 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.
Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH)
Time Frame: Immediate Post-intervention Assessment (within 4 weeks after the completion 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)
Time Frame: 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.
Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH)
Time Frame: Immediate Post-intervention Assessment (within 4 weeks after the completion 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 NIRS
Time Frame: Pre-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.
Functional NIRS
Time Frame: Up to 8 to 10 weeks (within the intervention period)
The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured throughout the training sessions and direct assessments using functional NIRS.
Functional NIRS
Time Frame: Immediate Post-intervention Assessment (within 4 weeks after the completion 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 Outcomes
- Behavioural ratings on children's executive functions(Delayed Post-intervention Assessment (a 2-month follow up 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))
- 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))
- 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))
Investigators
Dr. Kathy Shum
Associate Professor
The University of Hong Kong