← Back to all trials
Recruiting
NCT07454798
A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine
Conditions: Migraine, Headache Disorders, Primary
Sex: All
Ages: 10 Years – 16 Years
Healthy volunteers: No
Phase: NA
Enrollment: 38
Sponsor: Children's Mercy Hospital Kansas City
Location: Children's Mercy Kansas City Missouri
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
Source: ClinicalTrials.gov (NCT07454798). StuddyBuddy aggregates publicly available trial information.
