Home-Based Virtual Reality Neurofeedback Program for Adolescents Aged 10 to 16 With Migraine A Study to Test Feasibility and Effects on Headache Outcomes

What this Trial Is About

Researchers are studying whether a home-based virtual reality VR neurofeedback program is feasible and acceptable for adolescents aged 10 to 16 years with migraine. This trial aims to see if teenagers can be successfully enrolled, randomized, and retained while completing VR sessions and study procedures, and whether the program might improve migraine-related disability and symptoms. The study compares Immersive Neurofeedback Self-Regulation Training INSeRT, which uses brain activity recorded from a wearable EEG headband, with a VR program that shows immersive imagery without neurofeedback or relaxation training. Participants complete a 4-week baseline period involving headache logs, questionnaires, and a lab EEG assessment. Then they are randomly assigned to either the INSeRT neurofeedback VR or the comparison VR imagery program. Both groups do VR sessions at home three times a week, each lasting about 8 minutes, over 4 weeks. Questionnaires and a repeat EEG assessment are done after treatment and again approximately 3 months later. During the study, participants log headaches, complete questionnaires, and undergo EEG brain activity tests to measure changes. Researchers track recruitment, randomization, treatment adherence, retention, and symptom changes. Outcomes include the number and duration of VR sessions completed, treatment credibility, cybersickness symptoms, and migraine disability scores. Participants are followed for about 3 months after treatment to assess longer-term effects and safety.

A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine