Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303687
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-02-06
Brief Title:
VR-PAT and fNIRS to Identify CNS Biomarkers of Pain
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Imaging Pain in a Virtual World Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Pain Management in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to use functional near-infrared spectroscopy fNIRS to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality VR
Detailed Description:
The objective of this study is to develop central nervous system CNS biomarkers of pain experience during inpatient pediatric age 6-17 years burn dressing changes and pain relief induced by virtual reality VR We plan 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 andor monitoring response to VR-based pain reduction approaches for pain management in clinical trials
We will collaborate through a team science model to recruit n4 pediatric burn injury subjects 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 standard clinical procedure burn dressing changes
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
We will collaborate through a team science model to recruit n4 pediatric burn injury subjects 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 standard clinical procedure burn dressing changes
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None