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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 12
Healthy Volunteers: f
View:

• Children aged 7- 12

• Clinical diagnosis of ADHD

• Significant teacher- or parent-reported attention problems during screening

Locations
Other Locations
Hong Kong Special Administrative Region
The University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Que Zheng, PhD
adhdvr@hku.hk
852-39175870
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 138
Treatments
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.
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.
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.
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov