Feasibility trial of home-based immersive neurofeedback self-regulation training (insert) for the preventive treatment of pediatric migraine

The National Center for Complementary and Integrative Health awarded Children's Mercy Hospital $1.506 million under the Research and Training in Complementary and Integrative Health program (CFDA 93.213) on September 22, 2025, for a pre-efficacy feasibility trial of home-based immersive neurofeedback self-regulation training (INSERT) for pediatric migraine prevention.

The trial enrolls 38 participants aged 10–16 years diagnosed with migraine to evaluate enrollment, retention, randomization, and outcome assessment procedures for a future efficacy trial, and to determine feasibility of completing the INSERT treatment protocol. The intervention integrates data from a wearable electroencephalogram (EEG) headband into content viewed on an immersive virtual reality headset, designed to enable children to self-modulate cortical excitability and reduce vulnerability to future migraine attacks. During baseline, participants complete patient-reported outcome measures, four weeks of migraine logs, and a lab-based EEG protocol to comprehensively evaluate baseline cortical reactivity.

Work is performed in Kansas City, Missouri, with a period of performance through August 31, 2028. University of Kansas Medical Center Research Institute, Inc., serves as sub-recipient and performs electroencephalogram protocol development, implementation with 42 participants at baseline and immediate post-treatment timepoints, data management and analysis, progress reporting, and participation in investigative team meetings and manuscript development. Dr. Lepping and Dr. Liao oversee EEG protocol standardization, data collection, and analysis in coordination with the prime site investigator at Children's Mercy.

Abstract

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.