Comparative Effectiveness of fNIRS-Based Neurofeedback Training in Children With ADHD: The Impact of Virtual Reality Integration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Children's ADHD symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 7- 12
- •Clinical diagnosis of ADHD
- •Significant teacher- or parent-reported attention problems during screening
排除标准
- •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
研究组 & 干预措施
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.
干预措施: fNIRS-based neurofeedback (Behavioral)
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.
干预措施: fNIRS-based neurofeedback (Behavioral)
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.
干预措施: Virtual Reality Simulated Classroom (Behavioral)
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.
干预措施: Virtual Reality Simulated Classroom (Behavioral)
结局指标
主要结局
Children's ADHD symptoms
时间窗: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
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.
Children's ADHD symptoms
时间窗: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
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.
Children's ADHD symptoms
时间窗: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
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.
次要结局
- 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(Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention))
- Number subtest of Children's Memory Scale (CMS)(Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention))
- Behavioural ratings on children's executive functions(Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention))
- 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))
- 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))
- Number subtest of Children's Memory Scale (CMS)(Pre-intervention Assessment (within 4 weeks before the commencement of the intervention))
- Number subtest of Children's Memory Scale (CMS)(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))
研究者
Dr. Kathy Shum
Associate Professor
The University of Hong Kong