A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine

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

Conditions

• Migraine
• Headache Disorders, Primary

Interventions

BEHAVIORAL

Immersive Neurofeedback Self-Regulation Training (INSeRT)

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.

BEHAVIORAL

Virtual Reality Imagery (No Neurofeedback)

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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Children's Mercy Hospital Kansas City

  lead OTHER

Principal Investigators

• Mark A Connelly, PhD · Children's Mercy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2028-05-31

Completion

2028-05-31

Countries

• United States

Study Locations