Actively Recruiting
A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine
Led by Children's Mercy Hospital Kansas City · Updated on 2026-05-06
38
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
C
Children's Mercy Hospital Kansas City
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Mercy
Kansas City, Missouri, United States, 64108
Actively Recruiting
Research Team
M
Mark A Connelly, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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