A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Feasibility of Recruitment and Enrollment [Срок оценки: From study initiation through completion of enrollment (approximately 24 months)]
• Feasibility of Randomization and Treatment Initiation [Срок оценки: From enrollment through completion of pre-treatment preparation phase (approximately 6 weeks after enrollment)]
• Treatment Credibility (Child-Adapted Credibility/Expectancy Questionnaire - Credibility Subscale) [Срок оценки: Pre-treatment]
• Percent of Prescribed Virtual Reality Sessions Completed [Срок оценки: During the 4-week intervention phase]
• Mean Duration of Virtual Reality Sessions [Срок оценки: During the 4-week intervention phase]
• Cybersickness Symptoms Questionnaire (CSQ-VR) Mean Total Score [Срок оценки: Post-treatment survey window (Day 72 through Day 86 after baseline)]
• Child-Adapted System Usability Scale (SUS) Total Score [Срок оценки: Post-treatment survey window (Day 72 through Day 86 after baseline)]
• Retention Through 3-Month Follow-Up [Срок оценки: Up to approximately 162 days after baseline/enrollment]

Вторичные конечные точки (7)

• Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score (30-day) [Срок оценки: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)]
• Change in Headache Frequency [Срок оценки: 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).]
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety T-Score (8-Item Short Form) [Срок оценки: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)]
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression T-Score (8-Item Short Form) [Срок оценки: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)]
• Change in Perceived Stress Scale (PSS-10) Total Score [Срок оценки: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase).]
• Change in Pain Self-Efficacy Scale Total Score (7-Item Version) [Срок оценки: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)]
• Change in Pain Catastrophizing Scale - Child (PCS-C) Total Score [Срок оценки: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Children's Mercy — Kansas City

Публикации

• Connelly M, Boorigie M, McCabe K. Acceptability and Tolerability of Extended Reality Relaxation Training with and without Wearable Neurofeedback in Pediatric Migraine. Children (Basel). 2023 Feb 9;10(2):329. doi: 10.3390/children10020329. PMID 36832458

Идентификаторы

NCT: NCT07454798 · STUDY00002995 · 1R34AT013083-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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