A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Children's Mercy Hospital Kansas City
Study ID
NCT07454798
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • Immersive Neurofeedback Self-Regulation Training (INSeRT) — BEHAVIORAL
    A home-based behavioral intervention that integrates real-time EEG signals from a wearable headband into a virtual reality environment to provide neurofeedback during brief self-regulation training sessions. Participants complete sessions three times per week for approximately 8 minutes per session over 4 weeks.
  • Virtual Reality Imagery (No Neurofeedback) — BEHAVIORAL
    A home-based virtual reality imagery experience delivered without neurofeedback or guided relaxation training. Participants complete sessions three times per week for approximately 8 minutes per session over 4 weeks.

Study Details

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

Key Dates

Start date
May 13, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immersive Neurofeedback Self-Regulation Training (INSeRT)
    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.
  • Active Comparator: Virtual Reality Imagery (No Neurofeedback)
    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.

Primary Outcome Measure

Feasibility of Recruitment and Enrollment [ Time Frame: From study initiation through completion of enrollment (approximately 24 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's MercyKansas CityMissouri64108
Priscilla Connell, PhD
[email protected]
816-816-6979
Mark Connelly, PhD
[email protected]
816-234-3193

Find similar trials in Kansas City, MO

By condition
Migraine
By specialty
Neurology
By research site
Children's Mercy· Kansas City, MO

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