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
Age range
10 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Feasibility of Recruitment and Enrollment
Timeframe: From study initiation through completion of enrollment (approximately 24 months)
Feasibility of Randomization and Treatment Initiation
Timeframe: From enrollment through completion of pre-treatment preparation phase (approximately 6 weeks after enrollment)
Treatment Credibility (Child-Adapted Credibility/Expectancy Questionnaire - Credibility Subscale)
Timeframe: Pre-treatment
Percent of Prescribed Virtual Reality Sessions Completed
Timeframe: During the 4-week intervention phase
Mean Duration of Virtual Reality Sessions
Timeframe: During the 4-week intervention phase
Cybersickness Symptoms Questionnaire (CSQ-VR) Mean Total Score
Timeframe: Post-treatment survey window (Day 72 through Day 86 after baseline)
Child-Adapted System Usability Scale (SUS) Total Score
Timeframe: Post-treatment survey window (Day 72 through Day 86 after baseline)
Retention Through 3-Month Follow-Up
Timeframe: Up to approximately 162 days after baseline/enrollment