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A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine

RecruitingNAAges 10 Years - 16 YearsAllChildren's Mercy Hospital Kansas City
NCT07454798 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Partic

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📋 Eligibility rules (as published)
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
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What it tests

  • Immersive Neurofeedback Self-Regulation Training (INSeRT)
  • Virtual Reality Imagery (No Neurofeedback)
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Where

1 site
Children's Mercy
Kansas City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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