Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Anxiety and Pain Management
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Difference in brain activation picked up on fNIRS between the active VR, passive VR, iPad game, and control conditions
研究概览
简要总结
The objective of this study is to develop central nervous system (CNS) biomarkers of pain experienced during medical procedures and pain relief induced by Virtual Reality Pain Alleviation Therapy (VR-PAT). The study team plans to use innovative functional near-infrared spectroscopy (fNIRS) to identify and quantify the targeted CNS biomarkers. The ultimate goal of this project is to optimize the CNS biomarkers for predicting and/or monitoring response to virtual reality (VR)-based pain reduction approaches for pain management in clinical trials.
20 healthy children will be recruited for a 1-hour research visit where they will wear a blood pressure cuff to simulate pain and an fNIRS neuroimaging device while playing an immersive/engaging VR game, a passive VR video, and an iPad game.
详细描述
The objective of this study is to develop central nervous system (CNS) biomarkers of pain experienced during medical procedures and pain relief induced by Virtual Reality Pain Alleviation Therapy (VR-PAT). The study team plans to use innovative functional near-infrared spectroscopy (fNIRS) to identify and quantify the targeted CNS biomarkers. The ultimate goal of this project is to optimize the CNS biomarkers for predicting and/or monitoring response to VR-based pain reduction approaches for pain management in clinical trials.
Collaboration will occur through a team science model to address the following three specific aims:
Aim 1: To quantify the central nervous system (CNS) responses associated with self-reported pain intensity during a simulated pain condition.
Aim 2: To assess brain response patterns to virtual reality (VR)-based interventions for pain management.
Aim 3: To assess the degree to which objective brain measures and brain responses to VR intervention modulate objective brain markers of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6-17 years, inclusive
- •Subjects and legal guardians can communicate (read and write) using English
排除标准
- •Currently experiencing any pain (acute or chronic)
- •Took any pain medication within the past 12 hours
- •Vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
- •History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
- •Minors in foster care, incarcerated, or currently pregnant
研究组 & 干预措施
Control
Participants will wear an fNIRS neuroimaging device and undergo an experimental pain session using a blood pressure cuff around the calf. No distraction tool will be used.
iPad game
Participants will wear an fNIRS neuroimaging device and undergo an experimental pain session using a blood pressure cuff around the calf. Participants actively play the same VR game on an iPad, without the immersion of a VR headset.
干预措施: iPad (Other)
Active VR-PAT
Participants will wear an fNIRS neuroimaging device and undergo an experimental pain session using a blood pressure cuff around the calf. Participants actively play an engaging virtual reality game on a VR headset.
干预措施: Active VR-PAT (Other)
Passive VR-PAT
Participants will wear an fNIRS neuroimaging device and undergo an experimental pain session using a blood pressure cuff around the calf. Participants view a video of the same VR game on a VR headset, without engagement.
干预措施: Passive VR-PAT (Other)
结局指标
主要结局
Difference in brain activation picked up on fNIRS between the active VR, passive VR, iPad game, and control conditions
时间窗: Assessed continuously throughout the simulated pain session (60 minutes) for one visit
Mean within subject fNIRS signals of brain activation
次要结局
未报告次要终点
研究者
Henry Xiang
Director, Center for Pediatric Trauma Research
Nationwide Children's Hospital