Home-based VR neurofeedback for adolescents with migraine
Official title: Feasibility of Home-based Immersive Neurofeedback Self-regulation Training (INSeRT) for Youth With Migraine
Run by Children's Mercy Hospital Kansas City · NCT07454798 · Data updated 2026-11-12
This program tests whether a home-based virtual reality system guided by a wearable EEG headband can help adolescents (ages 10–16) who have migraine.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 16 Years |
| Sex | All |
| Enrollment | 38 (estimated) |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Status | Recruiting |
| Started | May 13, 2026 |
| Main results expected | May 31, 2028 |
| Study ends | May 31, 2028 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07454798 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are ages 10–16 with a specialist diagnosis of migraine (with/without aura or chronic), experiencing at least four migraine headaches per month with headache-free intervals, who can tolerate VR/headset use and do not have contraindicating conditions.
✕Probably not a fit
Patients with a history of epilepsy or photosensitive seizures, clinically elevated vestibular symptoms, significant physical/psychiatric/developmental limitations, recent start of a new preventive migraine medication, or current behavioral migraine therapy are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial enrolls adolescents with migraine and begins with a 4-week baseline period of headache logs and questionnaires plus a lab-based EEG assessment of cortical reactivity. Participants are then randomized to either Immersive Neurofeedback Self-Regulation Training (INSeRT), which uses real-time EEG to guide a VR experience, or to a comparison immersive VR imagery condition without neurofeedback or guided relaxation. The intervention is delivered at home via a wearable EEG headband paired with VR sessions, and adherence, retention, and completion of procedures are tracked to determine feasibility and acceptability. The study also collects preliminary headache-related outcome data to look for signals of reduced disability or symptom improvement.
Why it matters
Potential benefit: If successful, the program could offer adolescents a convenient, nonpharmacologic home-based tool to reduce migraine-related symptoms and disability.
How similar studies have gone: Neurofeedback and VR approaches have shown preliminary promise in small or clinic-based studies, but home-based EEG-guided VR for pediatric migraine is novel and not yet well tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Children's Mercy
Kansas City, Missouri, United States Recruiting
Study contacts
- Principal investigator: Mark A Connelly, PhD — Children's Mercy
- Study coordinator: Mark A Connelly, PhD
- Email: mconnelly1@cmh.edu
- Phone: 816-234-3193
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.