Headache Disorders, Primary, Migraine
Conditions
Keywords
Pediatric migraine, Adolescents, Neurofeedback, Virtual reality, Electroencephalogram, EEG, Cortical excitability, Self-regulation, Biofeedback, Mind-body therapy
Brief 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
Detailed description
Migraine is a prevalent neurological disorder in children and adolescents and is associated with increasing disability, school impairment, and healthcare utilization during development. Altered cortical excitability has been hypothesized to contribute to migraine vulnerability in youth. Neurofeedback interventions are designed to facilitate self-regulation of neural activity; however, traditional neurofeedback approaches are often clinic-based, difficult for families to access consistently, and have limited pediatric-specific outcome data. This study evaluates the feasibility of Immersive Neurofeedback Self-Regulation Training (INSeRT) in adolescents aged 10-16 years diagnosed with migraine. INSeRT is a home-based intervention that integrates real-time electroencephalogram (EEG) signals from a wearable headband into an immersive virtual reality (VR) environment. The intervention is designed to provide feedback related to neural activity patterns associated with cortical reactivity and to support developmentally appropriate self-regulation skills. The trial uses a randomized, parallel-group design. Following a baseline/run-in phase that includes characterization of headache patterns and laboratory-based EEG assessment of cortical reactivity, participants are randomized to either: Immersive Neurofeedback Self-Regulation Training (EEG-guided VR), or A comparison immersive VR imagery condition without neurofeedback or guided relaxation training. Both groups complete structured VR sessions at home according to a standardized schedule. Laboratory-based EEG assessment of cortical reactivity is repeated post-treatment to evaluate mechanistic signals related to neural modulation in pediatric migraine. The primary objectives of this feasibility trial are to evaluate recruitment procedures, randomization processes, intervention adherence, retention, tolerability, and completeness of outcome data collection in adolescents with migraine. These data will inform refinement of study procedures and intervention parameters in preparation for a future fully powered pediatric efficacy trial. Exploratory analyses will examine preliminary patterns of change in headache-related disability and related clinical outcomes to estimate effect sizes and variability for future trial planning.
Interventions
BEHAVIORALImmersive 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.
BEHAVIORALVirtual 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
Children's Mercy Hospital Kansas City
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants are not masked because assignment is apparent based on the specific treatment materials the participant is provided. Randomization is implemented using coded group labels. Investigators, care providers, and outcome assessors remain blinded to allocation. A designated research assistant responsible for distributing intervention materials is unblinded and does not conduct outcome assessments or analyses.
Eligibility
Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment and Enrollment | From 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 Initiation | From 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 Completed | During 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 Sessions | During 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 Score | Post-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 Score | Post-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-Up | Up to approximately 162 days after baseline/enrollment | Proportion of randomized participants who complete the 3-month follow-up questionnaires and diary collection period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score (30-day) | Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase) | 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 | Baseline 4-week run-in period compared to 3-month follow-up diary period (approximately 90-118 days after completion of the 4-week treatment phase). | 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) | Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase) | 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) | Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase) | 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 Perceived Stress Scale (PSS-10) Total Score | Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase). | Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10). Items are rated on a 5-point scale from 0 (Never) to 4 (Very Often). Four positively worded items will be reverse-scored, and item responses will be summed to generate a total score ranging from 0 to 40. Higher scores indicate greater perceived stress. |
| Change in Pain Self-Efficacy Scale Total Score (7-Item Version) | Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase) | Pain-related self-efficacy will be assessed using a 7-item Pain Self-Efficacy Scale. Items are rated on a 5-point scale from 1 (Very unsure) to 5 (Very sure). Item responses will be summed to generate a total score ranging from 7 to 35, with higher scores indicating greater confidence in functioning despite pain. |
| Change in Pain Catastrophizing Scale - Child (PCS-C) Total Score | Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase) | Pain catastrophizing will be assessed using the 13-item Pain Catastrophizing Scale - Child version (PCS-C). Items are rated on a 5-point scale from 0 (Not at all) to 4 (Extremely). Item responses will be summed to generate a total score ranging from 0 to 52. Higher scores indicate greater pain catastrophizing. |
Countries
United States
Contacts
CONTACTMark A Connelly, PhD
PRINCIPAL_INVESTIGATORMark A Connelly, PhD
Children's Mercy
Outcome results
None listed