Overview
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
Description
Migraine is a prevalent neurological disorder in children and adolescents and is associated with increasing disability, school impairment, and healthcare utilization during development. Altered cortical excitability has been hypothesized to contribute to migraine vulnerability in youth. Neurofeedback interventions are designed to facilitate self-regulation of neural activity; however, traditional neurofeedback approaches are often clinic-based, difficult for families to access consistently, and have limited pediatric-specific outcome data.
This study evaluates the feasibility of Immersive Neurofeedback Self-Regulation Training (INSeRT) in adolescents aged 10-16 years diagnosed with migraine. INSeRT is a home-based intervention that integrates real-time electroencephalogram (EEG) signals from a wearable headband into an immersive virtual reality (VR) environment. The intervention is designed to provide feedback related to neural activity patterns associated with cortical reactivity and to support developmentally appropriate self-regulation skills.
The trial uses a randomized, parallel-group design. Following a baseline/run-in phase that includes characterization of headache patterns and laboratory-based EEG assessment of cortical reactivity, participants are randomized to either:
Immersive Neurofeedback Self-Regulation Training (EEG-guided VR), or
A comparison immersive VR imagery condition without neurofeedback or guided relaxation training.
Both groups complete structured VR sessions at home according to a standardized schedule. Laboratory-based EEG assessment of cortical reactivity is repeated post-treatment to evaluate mechanistic signals related to neural modulation in pediatric migraine.
The primary objectives of this feasibility trial are to evaluate recruitment procedures, randomization processes, intervention adherence, retention, tolerability, and completeness of outcome data collection in adolescents with migraine. These data will inform refinement of study procedures and intervention parameters in preparation for a future fully powered pediatric efficacy trial.
Exploratory analyses will examine preliminary patterns of change in headache-related disability and related clinical outcomes to estimate effect sizes and variability for future trial planning.
Eligibility
Inclusion Criteria:
- Age 10-16 years (inclusive)
- Diagnosis of migraine (with or without aura, or chronic migraine) by a qualified headache specialist
- At least 4 migraine headaches per month
- Presence of headache-free periods between migraine episodes
Exclusion Criteria:
- Significant physical, psychiatric, or developmental conditions that would limit ability to participate in study procedures
- Clinically elevated Pediatric Vestibular Symptoms Questionnaire (PVSQ) score (\>0.68) or new/worsening vestibular symptoms prior to randomization
- Initiation of a new migraine preventive medication within 4 weeks prior to randomization
- Current participation in behavioral treatment for migraine (e.g., cognitive behavioral therapy or biofeedback)
- History of epilepsy or photosensitive seizures
