A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine

Migraine is a prevalent neurological disorder in children and adolescents and is associated with increasing disability, school impairment, and healthcare utilization during development. Altered cortical excitability has been hypothesized to contribute to migraine vulnerability in youth. Neurofeedback interventions are designed to facilitate self-regulation of neural activity; however, traditional neurofeedback approaches are often clinic-based, difficult for families to access consistently, and have limited pediatric-specific outcome data. This study evaluates the feasibility of Immersive Neurofeedback Self-Regulation Training (INSeRT) in adolescents aged 10-16 years diagnosed with migraine. INSeRT is a home-based intervention that integrates real-time electroencephalogram (EEG) signals from a wearable headband into an immersive virtual reality (VR) environment. The intervention is designed to provide feedback related to neural activity patterns associated with cortical reactivity and to support developmentally appropriate self-regulation skills. The trial uses a randomized, parallel-group design. Following a baseline/run-in phase that includes characterization of headache patterns and laboratory-based EEG assessment of cortical reactivity, participants are randomized to either: Immersive Neurofeedback Self-Regulation Training (EEG-guided VR), or A comparison immersive VR imagery condition without neurofeedback or guided relaxation training. Both groups complete structured VR sessions at home according to a standardized schedule. Laboratory-based EEG assessment of cortical reactivity is repeated post-treatment to evaluate mechanistic signals related to neural modulation in pediatric migraine. The primary objectives of this feasibility trial are to evaluate recruitment procedures, randomization processes, intervention adherence, retention, tolerability, and completeness of outcome data collection in adolescents with migraine. These data will inform refinement of study procedures and intervention parameters in preparation for a future fully powered pediatric efficacy trial. Exploratory analyses will examine preliminary patterns of change in headache-related disability and related clinical outcomes to estimate effect sizes and variability for future trial planning.