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A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine

Study acronym: INSeRT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Start date changed from estimate of May 2026 to May 13, 2026v4
  2. Notable Recruitment opened
    • Start date: Apr 30, 2026 to May 2026
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Apr 2026 to Apr 30, 2026
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07454798
Lead Sponsor Children's Mercy Hospital Kansas City
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Conditions
(from sponsor)
Migraine, Headache Disorders, Primary
Related terms Headache Disorders, Primary, Migraine Disorders, Self-Control
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov