Virtual Reality Neurofeedback for Migraine

(INSeRT Trial)

This trial explores whether a virtual reality program can help adolescents manage migraine symptoms more effectively. It seeks to determine if VR combined with neurofeedback—a method using brain activity to guide the VR experience—is practical and effective. Participants will use either a neurofeedback VR program, called Immersive Neurofeedback Self-Regulation Training (INSeRT), or a standard VR program at home. Adolescents who frequently experience migraines but have headache-free periods between episodes may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to investigate innovative migraine management techniques using advanced VR technology.

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot start a new migraine preventive medication within 4 weeks before joining the trial.

Research has shown that neurofeedback, a component of the Immersive Neurofeedback Self-Regulation Training (INSeRT), is generally safe and well-tolerated. Studies using similar neurofeedback methods have found that participants often report better control over migraines, with no serious side effects. For example, previous research found that neurofeedback reduced the frequency and severity of migraines without causing harm.

Additionally, the virtual reality (VR) experiences used in the study, similar to those in the comparison VR imagery program, have been tested in other settings. These experiences have been found acceptable and tolerable for young people with migraines.

Researchers are excited about the Virtual Reality Neurofeedback for Migraine treatment because it offers a novel approach to managing migraines using technology. Unlike standard migraine treatments, which often involve medications like triptans or NSAIDs, this method uses immersive virtual reality combined with real-time EEG neurofeedback. This unique approach aims to help patients self-regulate brain activity, potentially reducing migraine frequency and intensity without the need for drugs. Additionally, the treatment is home-based and requires only short, manageable sessions, making it convenient and accessible.

This trial will compare two different virtual reality interventions for migraine management. Participants in one arm will receive Immersive Neurofeedback Self-Regulation Training (INSeRT), which uses real-time EEG signals to provide neurofeedback during virtual reality sessions. Studies have shown that neurofeedback can help reduce migraines by teaching the brain to better control its activity. In one study with young people who have migraines, after 10 sessions of neurofeedback, participants experienced a clear drop in migraine frequency. Neurofeedback works by focusing on brain patterns that lead to headaches. Combining neurofeedback with mindfulness techniques has also shown promise in managing migraines and relieving headaches. Overall, early research suggests that neurofeedback could be a useful tool for reducing migraine symptoms and improving the quality of life for those affected. Meanwhile, participants in the other arm will receive a Virtual Reality Imagery experience without neurofeedback, serving as an active comparator in this trial.¹⁴⁶⁷⁸