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

NCT06743763 | Active Not Recruiting DMC

• 1 other identifier: EA200247(RCT2)
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD)

Keywords

neurofeedback; fNIRS; ADHD; children; virtual reality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Conners Continuous Performance Test 3rd Edition (CPT 3)

  Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)

• Conners Continuous Performance Test 3rd Edition (CPT 3)

  Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)

• Conners Continuous Performance Test 3rd Edition (CPT 3)

  Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)

• Functional NIRS

  Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)

• Functional NIRS

  Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)

Other Outcomes (2)

• 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

  Up to 8 to 10 weeks (within the intervention period)

Study Arms (3)

fNIRS-NFT with VR

EXPERIMENTAL

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; Behavioral: Virtual Reality Simulated Classroom

fNIRS-NFT without VR

ACTIVE COMPARATOR

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

VR without fNIRS-NFT

ACTIVE COMPARATOR

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

Interventions

fNIRS-based neurofeedback BEHAVIORAL

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.

fNIRS-NFT with VR; fNIRS-NFT without VR

Virtual Reality Simulated Classroom BEHAVIORAL

A simulated classroom scenario is integrated in VR setting and children are asked to complete academic tasks in the simulated classroom.

VR without fNIRS-NFT; fNIRS-NFT with VR

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kar-man Kathy Shum, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Experimental group: receives 8-week functional near-infrared spectroscopy (fNIRS) neurofeedback training (coupled with virtual reality), twice per week, each lasting 1 hour. Comparative group 1: receives 8-week functional near-infrared spectroscopy (fNIRS) neurofeedback training without virtual reality(VR) technology, twice per week, each lasting 1 hour. Comparative group 2: receives 8-week training using VR technology (without neurofeedback) twice per week, each lasting 1 hour.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: December 1, 2024
• Primary Completion: April 17, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning immediately after publication and ending 5 years after publication.
• 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).

Locations

HK (1)