Feasibility of Home-based Immersive Neurofeedback Self-regulation Training (INSeRT) for Youth With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Feasibility of Recruitment and Enrollment
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Immersive Neurofeedback Self-Regulation Training (INSeRT)
Participants receive a home-based immersive virtual reality intervention that integrates real-time EEG signals from a wearable headband to provide neurofeedback during virtual reality sessions. Sessions are completed three times per week for approximately 8 minutes per session over 4 weeks.
干预措施: Immersive Neurofeedback Self-Regulation Training (INSeRT) (Behavioral)
Virtual Reality Imagery (No Neurofeedback)
Participants receive a home-based immersive virtual reality imagery experience without neurofeedback and without guided relaxation training. Sessions are completed three times per week for approximately 8 minutes per session over 4 weeks.
干预措施: Virtual Reality Imagery (No Neurofeedback) (Behavioral)
结局指标
主要结局
Feasibility of Recruitment and Enrollment
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Up to approximately 162 days after baseline/enrollment
Proportion of randomized participants who complete the 3-month follow-up questionnaires and diary collection period.
次要结局
- 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))
- 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).)
- 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))
- 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))
- 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).)
- 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))
- 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))
研究者
Mark Connelly
Professor of Pediatrics
Children's Mercy Hospital Kansas City