Healthy Children and Virtual Reality Mediation of Simulated Pain
Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Anxiety and Pain Management
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 6-17 years, inclusive
- Subjects and legal guardians can communicate (read and write) using English
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: 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.
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Experimental: 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.
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Virtual Reality Pain Alleviation Tool (VR-PAT) hosted on a Pico Neo 3 Pro Eye headset.
Both engagement and immersion.
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Active Comparator: 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.
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VR-PAT hosted on a Pico Neo 3 Pro Eye headset, with the active game participation removed.
Immersion with engagement removed.
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Active Comparator: 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.
|
VR-PAT hosted on an Apple iPad.
Engagement with immersion removed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difference in brain activation picked up on fNIRS between the active VR, passive VR, iPad game, and control conditions
Time Frame: Assessed continuously throughout the simulated pain session (60 minutes) for one visit
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Mean within subject fNIRS signals of brain activation
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Assessed continuously throughout the simulated pain session (60 minutes) for one visit
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Henry Xiang, MD, MPH, PhD, MBA, Nationwide Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004727
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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