A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine

The goal of this clinical trial is to learn whether a home-based virtual reality (VR) neurofeedback program is feasible and acceptable for adolescents with migraine. The study will also explore whether the program may improve headache-related outcomes. The main questions it aims to answer are: Is it feasible to enroll, randomize, and retain adolescents with migraine in this study? Do participants complete the VR sessions and study procedures as intended? Are there preliminary signals that the VR neurofeedback program may improve headache-related disability and symptoms? Researchers will compare Immersive Neurofeedback Self-Regulation Training (INSeRT), which uses brain activity recorded from a wearable electroencephalogram (EEG) headband to guide the VR experience, to a comparison VR program that presents immersive imagery without neurofeedback or guided relaxation training. Participants will: Complete a 4-week baseline period that includes headache logs, questionnaires, and a laboratory EEG assessment Be randomly assigned to one of two VR programs Complete VR sessions at home three times per week for 4 weeks Complete questionnaires at the end of treatment and again approximately 3 months later Repeat the laboratory EEG assessment at the end of treatment

NCT Number	NCT07454798
Lead Sponsor	Children's Mercy Hospital Kansas City Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Conditions	Migraine, Headache Disorders, Primary
Enrollment	38 participants
Start Date	2026-05-13
Primary Completion	2028-05-31 (estimated)
Study Completion	2028-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-03