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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.
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.
Age
6 - 17 years
Sex
ALL
Healthy Volunteers
Yes
Nationwide Children's Hospital
Columbus, Ohio, United States
Start Date
August 4, 2025
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2026
Last Updated
March 17, 2026
20
ESTIMATED participants
Active VR-PAT
OTHER
Passive VR-PAT
OTHER
iPad
OTHER
Lead Sponsor
Nationwide Children's Hospital
NCT07360600
NCT07468006
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06356220