Virtual Reality Neurofeedback for Migraine
(INSeRT Trial)
What You Need to Know Before You Apply
What is the purpose of 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
Who Is on the Research Team?
Mark A Connelly, PhD
Principal Investigator
Children's Mercy
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline/Run-in
Participants complete a 4-week baseline period that includes headache logs, questionnaires, and a laboratory EEG assessment
Treatment
Participants complete VR sessions at home three times per week for 4 weeks, with a repeat laboratory EEG assessment at the end of treatment
Follow-up
Participants complete questionnaires and diary collection approximately 3 months after treatment to assess long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Immersive Neurofeedback Self-Regulation Training (INSeRT)
- Virtual Reality Imagery (No Neurofeedback)
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive a home-based immersive virtual reality intervention that integrates real-time EEG signals from a wearable headband to provide neurofeedback during virtual reality sessions. Sessions are completed three times per week for approximately 8 minutes per session over 4 weeks.
Participants receive a home-based immersive virtual reality imagery experience without neurofeedback and without guided relaxation training. Sessions are completed three times per week for approximately 8 minutes per session over 4 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Mercy Hospital Kansas City
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
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