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A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine

Feasibility of Home-based Immersive Neurofeedback Self-regulation Training (INSeRT) for Youth With Migraine

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 16 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Questionnaires, Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
  • "INSeRT is a home-based intervention that integrates real-time electroencephalogram (EEG) signals from a wearable headband into an immersive virtual reality (VR) environment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a home virtual reality (VR) program is practical and accepted by children ages 10–16 with migraines. The program uses a headband that records brain activity to guide the VR experience and is compared with VR without this feedback or guided relaxation. Researchers will also look for early signs that it may ease headache symptoms and their impact on daily life.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 10–16 years old.
  • Have migraines diagnosed by a qualified headache specialist, including migraines with or without aura (warning signs such as vision changes) or chronic migraines.
  • Have at least 4 migraine headaches each month.
  • Have times without headaches between migraine attacks.

Who can't join

  • Have a major physical, mental health, or developmental condition that would limit taking part.
  • Have a score above 0.68 on a questionnaire about dizziness and balance symptoms, or have new or worsening symptoms before being assigned to a VR group.
  • Started a new medicine to prevent migraines within 4 weeks before being assigned to a VR group.
  • Are currently in behavioral treatment for migraines, such as therapy to change thoughts and behaviors or biofeedback (training to control body responses).
  • Have a history of epilepsy or seizures triggered by flashing lights.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * History of epilepsy or photosensitive seizures

Study sites (1)

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