NCT07454798 A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine
| NCT ID | NCT07454798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Mercy Hospital Kansas City |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 38 participants in total. It began in 2026-05-13 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Mark A Connelly, PhD
PRINCIPAL INVESTIGATOR
Children's Mercy
Frequently Asked Questions
Who can join the NCT07454798 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 16 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07454798 currently recruiting?
Yes, NCT07454798 is actively recruiting participants. Contact the research team at mconnelly1@cmh.edu for enrollment information.
Where is the NCT07454798 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT07454798 clinical trial?
NCT07454798 is sponsored by Children's Mercy Hospital Kansas City. The principal investigator is Mark A Connelly, PhD at Children's Mercy. The trial plans to enroll 38 participants.
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