A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-16
SponsorChildren's Mercy Hospital Kansas City

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Immersive Neurofeedback Self-Regulation Training (INSeRT)
  • Virtual Reality Imagery (No Neurofeedback)

Treatment groups

38 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Mercy Hospital Kansas City

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator