Study protocol of a randomised controlled trial of the effects of near-infrared spectroscopy neurofeedback training coupled with virtual reality technology in children with ADHD.

backgroundThe rise in the number of children diagnosed with attention-deficit/hyperactivity disorder (ADHD) highlights the need for effective interventions targeting attentional control. Although recent research has demonstrated the potential of neurofeedback training (NFT) for children with ADHD, most studies have been conducted in laboratory settings, raising questions about their real-world applicability. To address this issue, virtual reality (VR) may offer a solution to the ecological validity challenges encountered in NFT. By coupling NFT with VR, individuals can engage in self-regulating brain activity within a simulated, realistic environment. This study aims to investigate the efficacy of near-infrared spectroscopy (NIRS)-based NFT combined with VR in alleviating ADHD symptoms among children, addressing the need for interventions with practical relevance and effectiveness.

methodsThis study aims to recruit 138 children aged 7-12 diagnosed with ADHD. Following baseline assessment, participants will be randomly assigned to one of three conditions: (1) NIRS-based NFT in a VR classroom setting; (2) conventional computerised cognitive training (active control) or (3) a waitlist control group. On completion of intervention sessions in the two training groups, all groups will undergo an assessment at time 2, with a follow-up assessment scheduled 2 months post-training for all participants. Primary outcomes will include measures of executive function, such as attentional control, response inhibition and working memory, along with changes in oxygenated and deoxygenated haemoglobin levels monitored by functional NIRS. Secondary outcome measures will comprise ratings of children's ADHD symptoms and executive function behaviours in daily life, reported by parents and teachers. DISCUSSION: The three-arm randomised controlled trial will address research gaps regarding the effectiveness of NIRS-based NFT for children with ADHD, particularly when integrated with immersive VR technology. By combining NFT and VR, this study aims to simulate a real-world environment, potentially amplifying intervention effects. The findings from the study will provide evidence for the efficacy of this innovative intervention in improving executive function and alleviating ADHD symptoms. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Human Research Ethics Committee at the University of Hong Kong (Reference: EA200247). Results will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: NCT05906485.