fNIRS-Based Neurofeedback Training in Children With ADHD: The Effects of VR (VR-fNIRS-RCT2)

Comparative Effectiveness of fNIRS-Based Neurofeedback Training in Children With ADHD: The Impact of Virtual Reality Integration

The study aims to explore whether the treatment using fNIRS-based neurofeedback training for children with attention-deficit/hyperactivity disorder (ADHD) is useful. Furthermore, the study hopes to evaluate whether the use of virtual reality (VR) technology will have an impact on the treatment's effectiveness.

The program includes the following components:

Participants will be randomly assigned to one of three intervention groups: the neurofeedback with virtual reality (VR) group, the 2D neurofeedback group (with no VR technology applied), and the VR without neurofeedback group. All participants will complete academic-related tasks in simulated lessons. Participants in the VR neurofeedback group will wear VR goggles and a neurofeedback device that measures blood oxy-hemoglobin levels in brain cortical tissue and provides feedback via visual images or auditory sounds to the participants. Those in the 2D neurofeedback group will use a computer to complete the tasks, with all other settings (e.g., neurofeedback settings) remaining the same. The VR without neurofeedback group will wear VR goggles to complete tasks, but without the neurofeedback component.

All participants will complete a total of 16 training sessions over 8 weeks (twice a week), with each session lasting approximately 35 to 60 minutes.

To investigate the intervention's effectiveness, children will be asked to complete a set of cognitive tests covering inhibitory control, attention, and working memory before 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 will be conducted at the laboratory at the University of Hong Kong. Additionally, parents and teachers will be asked to complete a questionnaire assessing children's behavior at home and at school at three time points.

Study Overview

• Status: Active, not recruiting
• Conditions: Attention Deficit Disorder With Hyperactivity (ADHD)
• Intervention / Treatment: Behavioral: fNIRS-based neurofeedback; Behavioral: Virtual Reality Simulated Classroom

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children aged 7- 12
• Clinical diagnosis of ADHD
• Significant teacher- or parent-reported attention problems during screening

Exclusion Criteria:

• Inability to answer the first five questions in 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fNIRS-NFT with VR; 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-based neurofeedback; fNIRS-based neurofeedback is provided during a simulated classroom scenario where the child participants are asked to learn to regulate their attention based on the feedback provided by the fNIRS on the oxygenated haemoglobin level in their prefrontal cortex.; Behavioral: Virtual Reality Simulated Classroom; A simulated classroom scenario is integrated in VR setting and children are asked to complete academic tasks in the simulated classroom.
Active Comparator: fNIRS-NFT without VR; The fNIRS-NFT without VR (NFT-2D 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 via a computer screen and participants will be asked to complete some academic-related tasks during the stimulated lessons by pressing a remote controller provided. 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 hopefully will learn to manipulate their attention, presumably by altering brain activities.	Behavioral: fNIRS-based neurofeedback; fNIRS-based neurofeedback is provided during a simulated classroom scenario where the child participants are asked to learn to regulate their attention based on the feedback provided by the fNIRS on the oxygenated haemoglobin level in their prefrontal cortex.
Active Comparator: VR without fNIRS-NFT; In the VR without fNIRS-NFT Training, we have designed a virtual reality classroom scenario modeled and children are asked to complete academic tasks in the VR setting but no neurofeedback will be provided.	Behavioral: Virtual Reality Simulated Classroom; A simulated classroom scenario is integrated in VR setting and children are asked to complete academic tasks in the simulated classroom.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's ADHD symptoms	Parents 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.	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Children's ADHD symptoms	Parents 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.	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Children's ADHD symptoms	Parents 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.	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conners Continuous Performance Test 3rd Edition (CPT 3)	A standardized computerized test on sustained attention and inhibitory control	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Conners Continuous Performance Test 3rd Edition (CPT 3)	A standardized computerized test on sustained attention and inhibitory control	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Conners Continuous Performance Test 3rd Edition (CPT 3)	A standardized computerized test on sustained attention and inhibitory control	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Number subtest of Children's Memory Scale (CMS)	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.	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Number subtest of Children's Memory Scale (CMS)	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.	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Number subtest of Children's Memory Scale (CMS)	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.	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Behavioural ratings on children's executive functions	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	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Behavioural ratings on children's executive functions	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	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Behavioural ratings on children's executive functions	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	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Functional NIRS	The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured during the direct assessment task of Conners Continuous Performance Test 3rd Edition (CPT3) using functional NIRS.	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
Functional NIRS	The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured during the direct assessment task of Conners Continuous Performance Test 3rd Edition (CPT3) using functional NIRS.	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Functional NIRS	The levels of oxygenated and deoxygenated hemoglobin of the prefrontal cortex will be measured during the direct assessment task of Conners Continuous Performance Test 3rd Edition (CPT3) using functional NIRS.	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's enjoyment of the training	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.	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
Feasibility of conducting VR training within children	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.	Up to 8 to 10 weeks (within the intervention period)

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Kar-man Kathy Shum, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): April 17, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: neurofeedback; ADHD; children; virtual reality; fNIRS
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: EA200247(RCT2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified individual participant data collected during the trial will be available upon reasonable request.
• IPD Sharing Time Frame: Beginning immediately after publication and ending 5 years after publication.
• IPD Sharing Access Criteria: To gain access, requestors will need to provide a clear research aim or methodological sound research plan directed to the principal investigator (kkmshum@hku.hk).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No