fNIRS-Based Neurofeedback Training in Children With ADHD: The Effects of VR
NCT ID: NCT06743763
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
138 participants
INTERVENTIONAL
2024-12-01
2025-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of ADHD
* Significant teacher- or parent-reported attention problems during screening
Exclusion Criteria
* 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
7 Years
12 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Dr. Kathy Shum
Associate Professor
Principal Investigators
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Kar-man Kathy Shum, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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The University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Jeanne Que Zheng, PhD
Role: primary
Other Identifiers
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EA200247(RCT2)
Identifier Type: -
Identifier Source: org_study_id