A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine (NCT07454798)
Feasibility of Home-based Immersive Neurofeedback Self-regulation Training (INSeRT) for Youth With Migraine
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Children's Mercy — Kansas City, Missouri
Age range: 10 Years to 16 Years
🧪 Interventions in This Study
- Immersive Neurofeedback Self-Regulation Training (INSeRT) (BEHAVIORAL)
- Virtual Reality Imagery (No Neurofeedback) (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Children's Mercy — Kansas City, Missouri
📞 Contact the Study Coordinator
Phone: (816) 234-3193
Email: mconnelly1@cmh.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Migraine
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- Treatment for Migraine and Mood — The Bronx, New York
- Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine — Birmingham, Alabama
- A Study to Evaluate White Matter Hyperintensities in Migraine — Phoenix, Arizona
- Migraine Manager (R01) — Cincinnati, Ohio
- Nerivio Efficacy Under High-Frequency Use — Bridgewater, New Jersey
Explore by condition: All Migraine clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.