fNIRS Neurofeedback Training Using Virtual Reality in Children With ADHD

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05906485
Collaborator
(none)
108
1
3
31.4
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: fNIRS Neurofeedback-VR Training
  • Behavioral: Computerized Cognitive Training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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).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).
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants will be randomly allocated into groups. Assessors do not know about which group participants were allocated.
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jan 11, 2026
Anticipated Study Completion Date :
Jan 11, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

Active Comparator: 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.

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.

Other: 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.

Behavioral: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Conners Continuous Performance Test 3rd Edition (CPT 3) [Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]

    A standardized computerized test on sustained attention and inhibitory control

  3. Conners Continuous Performance Test 3rd Edition (CPT 3) [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

  4. 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.

  5. Number subtest of Children's Memory Scale (CMS) [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.

  6. Number subtest of Children's Memory Scale (CMS) [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.

  7. 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.

  8. Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH) [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.

  9. Opposite Worlds subtest of the Test of Everyday Attention for Children (TEA-CH) [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.

  10. 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.

  11. Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH) [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.

  12. Creature Counting subtest of the Test of Everyday Attention for Children (TEA-CH) [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.

  13. Functional NIRS [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.

  14. Functional NIRS [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.

  15. Functional NIRS [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.

  16. Functional NIRS [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.

Secondary Outcome Measures

  1. Children's ADHD symptoms [Pre-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.

  2. Children's ADHD symptoms [Immediate Post-intervention Assessment (within 4 weeks after the completion 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.

  3. Children's ADHD symptoms [Delayed Post-intervention Assessment (a 2-month follow up after the completion 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.

  4. Behavioural ratings on children's executive functions [Pre-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

  5. Behavioural ratings on children's executive functions [Immediate Post-intervention Assessment (within 4 weeks after the completion 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

  6. Behavioural ratings on children's executive functions [Delayed Post-intervention Assessment (a 2-month follow up after the completion 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

  7. Children's classroom behaviours [Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)]

    Children's classroom behaviours, including their engagement and off-task behaviours, will be measured using a classroom observation scale based on the Behavioral Observation of Students in Schools (BOSS) developed by our research lab through naturalistic observation at schools. A proportion of participants will be selected randomly to undergo the classroom observation. The total scores for children's engagement and off-task behaviours ranges from 0 to 30, with a higher score indicating a higher level of engagement and off-task behaviours in class.

  8. Children's classroom behaviours [Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]

    Children's classroom behaviours, including their engagement and off-task behaviours, will be measured using a classroom observation scale based on the Behavioral Observation of Students in Schools (BOSS) developed by our research lab through naturalistic observation at schools. A proportion of participants will be selected randomly to undergo the classroom observation. The total scores for children's engagement and off-task behaviours ranges from 0 to 30, with a higher score indicating a higher level of engagement and off-task behaviours in class.

  9. Children's classroom behaviours [Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)]

    Children's classroom behaviours, including their engagement and off-task behaviours, will be measured using a classroom observation scale based on the Behavioral Observation of Students in Schools (BOSS) developed by our research lab through naturalistic observation at schools. A proportion of participants will be selected randomly to undergo the classroom observation. The scores for children's engagement and off-task behaviours ranges from 0 to 30, with a higher score indicating a higher level of engagement and off-task behaviours in class.

Other Outcome Measures

  1. Children's enjoyment of the training [Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]

    Children's enjoyment of the training will be evaluated using the Cognitive Absorption Scale (CAS) using a 7-point Likert scale (ranges from 1 to 7), which includes four dimensions: temporal dissociation, focused immersion, heightened enjoyment, and curiosity. The total score of this scale ranges from 7 to 119, with a higher score indicating a higher level of children's enjoyment of the training.

  2. Feasibility of conducting VR training within children [Up to 8 to 10 weeks (within the intervention period)]

    Children's symptoms of cybersickness (e.g., nausea, fatigue, eye strain) will be measured using the Simulator Sickness Questionnaire (SSQ) after completing every training session, using a 4-point Likert scale (ranges from 0 to 3). The minimum weighted total score of this scale is 0 and the maximum weighted total score is 235.62, with a higher score indicating a higher level of symptoms of cybersickness.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 12 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Kathy Kar Man SHUM, Dr., The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Kathy Shum, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05906485
Other Study ID Numbers:
  • EA200247
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Kathy Shum, Associate Professor, The University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023