Feasibility Study of Virtual Reality Neurofeedback for Adolescent Migraine
This study is looking into whether a home-based virtual reality (VR) program called Immersive Neurofeedback Self-Regulation Training (INSeRT) is practical and helpful for adolescents (ages 10-16) who experience migraines. INSeRT uses a wearable headband to detect brain signals (EEG) and shows them in a VR environment to help you learn to control them. Another group will experience VR imagery without neurofeedback. The main goals are to see if it's easy to recruit and keep participants in the study, if they complete the VR sessions as planned, and if there are early signs that INSeRT might improve migraine symptoms and how much they affect daily life. You could be eligible if you are 10-16 years old, have been diagnosed with migraine by a specialist, and experience at least 4 migraines per month with headache-free periods in between.
- Study design
- This is an interventional study with a planned enrollment of 38 participants. It uses a randomized, parallel-group design, meaning participants will be randomly assigned to one of two groups.
- What's involved
- Participants will complete home-based VR sessions three times per week for approximately 8 minutes per session over 4 weeks. There will also be pre-treatment preparations lasting about 6 weeks after enrollment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures feasibility of recruitment and enrollment for approximately 24 months, and feasibility of randomization and treatment initiation for approximately 6 weeks after enrollment.
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A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mark A Connelly, PhD · PRINCIPAL_INVESTIGATOR · Children's Mercy
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Feasibility of Recruitment and EnrollmentFrom study initiation through completion of enrollment (approximately 24 months)
Recruitment feasibility will be assessed by the number of participants screened and enrolled per month and the proportion of eligible participants who consent to participate.
- Feasibility of Randomization and Treatment InitiationFrom enrollment through completion of pre-treatment preparation phase (approximately 6 weeks after enrollment)
Proportion of enrolled participants who complete the baseline/run-in phase, are successfully randomized, and complete the initial intervention training call prior to starting treatment.
- Treatment Credibility (Child-Adapted Credibility/Expectancy Questionnaire - Credibility Subscale)Pre-treatment
Adapted 3-item Credibility scale derived from the Credibility/Expectancy Questionnaire (CEQ), modified for developmental appropriateness for youth ages 10-16. Items rated on a 5-point Likert scale; higher scores indicate greater perceived treatment credibility.
- Percent of Prescribed Virtual Reality Sessions CompletedDuring the 4-week intervention phase
Adherence to the virtual reality intervention measured as the percent of prescribed sessions completed during the 4-week intervention phase. Participants were prescribed 3 sessions per week for 4 weeks (12 total sessions). Percent adherence will be calculated as: (number of completed sessions ÷ 12) × 100, based on portal-derived usage analytics. Higher values indicate greater adherence.
- Mean Duration of Virtual Reality SessionsDuring the 4-week intervention phase
Adherence to the virtual reality intervention measured as the average duration (in minutes) of completed VR sessions during the 4-week intervention phase, based on portal-derived usage analytics. Higher values indicate longer session engagement.
- Cybersickness Symptoms Questionnaire (CSQ-VR) Mean Total ScorePost-treatment survey window (Day 72 through Day 86 after baseline)
Cybersickness symptoms will be assessed using a child-adapted version of the Cybersickness Symptoms Questionnaire in Virtual Reality (CSQ-VR). Participants rate the extent to which they experienced symptoms such as nausea, dizziness, visual discomfort, and imbalance during or after VR sessions on a 1 to 5 scale (1 = Not at all, 5 = A lot). Item scores will be averaged to create a mean total score, with higher scores indicating greater cybersickness symptoms. Spontaneously reported adverse events will also be recorded in the study adverse event log and summarized descriptively as an indicator of treatment tolerability.
- Child-Adapted System Usability Scale (SUS) Total ScorePost-treatment survey window (Day 72 through Day 86 after baseline)
A child-adapted version of the System Usability Scale (SUS) will be used to assess perceived usability of the virtual reality system. The SUS is a 10-item self-report questionnaire rated on a 5-point Likert scale (Strongly Disagree to Strongly Agree). Scores are calculated using standard SUS scoring procedures and transformed to a total score ranging from 0 to 100, with higher scores indicating greater perceived usability.
- Retention Through 3-Month Follow-UpUp to approximately 162 days after baseline/enrollment
Proportion of randomized participants who complete the 3-month follow-up questionnaires and diary collection period.