Feasibility Trial of Home-Based Immersive Neurofeedback Self-Regulation Training (INSeRT) for the Preventive Treatment of Pediatric Migraine - Summary. Migraine is a highly prevalent neurological disease in children for which there remains a critical need for well-accepted, safe and effective preventive treatments to mitigate the progression toward a more chronic and costly condition. Cortical excitability is hypothesized to play a key role in maintaining the vulnerability to future migraine attacks. Neurofeedback is a mind-body approach that may facilitate one's ability to self-regulate cortical reactivity. However, neurofeedback in usual care settings is often difficult for families to access reliably, and there is a lack of outcome data specifically for pediatric migraine. In preliminary work, we found that children with migraine responded positively to a neurofeedback-assisted self-regulation treatment that integrates data from a wearable electroencephalogram (EEG) headband into content viewed on an immersive virtual reality headset ( Immersive Neurofeedback Self-Regulation Training - INSeRT). We hypothesize that using this intervention prospectively from home may be a practical and appealing approach for children to learn to self-modulate cortical excitability, thereby reducing their vulnerability to future migraine attacks. The current proposal seeks to further evaluate this idea by means of a pre-efficacy feasibility trial. Specific aims are: (1) to evaluate and hone the enrollment, retention, randomization, and outcome assessment procedures planned for a future efficacy trial of the INSeRT intervention, and (2) to determine the feasibility in children with migraine of completing the INSeRT treatment protocol. During a baseline phase, 38 participants (ages 10-16 years) diagnosed with migraine will complete patient-reported outcome measures, 4 weeks of migraine logs, and a lab-based EEG protocol designed to comprehensively evaluate baseline cortical reactivity. After completion of the baseline phase, participants will be randomized into one of two groups: (a) Immersive Neurofeedback Self-Regulation Training, or (b) a comparator group that will only view immersive imagery (without guided relaxation training or neurofeedback). Both groups will receive training on how to complete the procedures from home, following a schedule of three sessions per week (approximately 8 minutes per session) for a duration of four weeks. Participants will complete outcome measures remotely at post-treatment and again at a 3-month follow-up timepoint; the lab-based EEG protocol for assessing cortical reactivity will be repeated at the post-treatment timepoint. The primary trial endpoints comprise metrics related to intervention feasibility (i.e., treatment adherence, acceptability and tolerability) and trial feasibility (i.e., rates of enrollment and randomization, retention, and outcome measure completion). These data will inform whether further testing of this intervention approach is warranted, and if so, how to optimize parameters of the intervention and study procedures for a future successful efficacy trial. The planned work is significant as it will enhance our understanding of preventing migraine attacks through mechanism-informed mind-body treatments, potentially expanding pediatric options for reducing disease progression.
