A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine

Feasibility of Recruitment and Enrollment

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 Initiation

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)

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 Completed

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.

Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score (30-day)

Migraine-related disability will be assessed using the Pediatric Migraine Disability Assessment (PedMIDAS). In this study, items assess number of days of disability during the past 30 days. The 30-day total score will be multiplied by 3 to generate a 90-day equivalent score for comparability with the original instrument. Total scores range from 0 to 240, with higher scores indicating greater migraine-related disability.

Change in Headache Frequency

Headache frequency will be measured using prospective electronic daily migraine diaries. A headache day is defined as any calendar day in which the participant reports a headache. The outcome will be the total number of headache days recorded during each 4-week monitoring period. Possible range: 0 to 28 days. Higher values indicate greater headache frequency.

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety T-Score (8-Item Short Form)

Anxiety symptoms will be assessed using the 8-item PROMIS Pediatric Anxiety short form. Items are rated on a 5-point scale (Never to Always). Raw scores will be converted to standardized PROMIS T-scores (mean = 50, SD = 10), with higher scores indicating greater anxiety symptoms.

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression T-Score (8-Item Short Form)

Depressive symptoms will be assessed using the 8-item PROMIS Pediatric Depression short form. Items are rated on a 5-point scale (Never to Always). Raw scores will be converted to standardized PROMIS T-scores (mean = 50, SD = 10), with higher scores indicating greater depressive symptoms.

Change in Resting EEG State EEG Spectral Power

Mean cortical source power derived from resting-state electroencephalography (EEG), calculated across standard frequency bands (delta, theta, alpha, beta, and gamma) using source-localized analysis. Power values (µV²) will be averaged within predefined brain regions (frontal, occipital, and temporal areas). Change from baseline to post-treatment will be explored.

Changes in Movement-Related EEG Spectral Power During Finger-Tapping Task

Movement-related spectral power (µV²) derived from EEG recordings during a finger-tapping task, calculated across standard frequency bands using source-localized analysis. Power values will be averaged across predefined cortical regions. Change from baseline to post-treatment will be examined.

Changes in Finger-Tapping Reaction Time

Mean reaction time (milliseconds) during a finger-tapping task performed during EEG assessment. Change from baseline to post-treatment will be examined.