Clinical trial NCT06303687: VR-PAT and FNIRS to Identify CNS Biomarkers of Pain
Official title: Imaging Pain in a Virtual World: Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Pain Management in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Pain
Pediatric ALL
Procedural Pain
Burns
Keywords: Virtual Reality
VR
fNIRS
Pain
Biomarker
Neuroimaging
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to either the intervention (fNIRS and VR-PAT) or the control (fNIRS and standard of care) at the first research dressing change and will then crossover to the alternative group for the second laser procedure.
Primary purpose: DIAGNOSTIC

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 and/or monitoring response to VR-based pain reduction approaches for pain management in clinical trials.

We will collaborate through a team science model to recruit n=4 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.

Eligibility criteria: Inclusion Criteria:

1. Being treated for acute burn injury
2. Age 6-17 years, inclusive
3. Admitted to NCH burn unit for treatment
4. Have a dressing that requires daily changes over 3 days
5. Patient and family caregivers can communicate (read and write) using English

Exclusion Criteria:

1. Any wounds that may interfere with study procedures
2. Vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
3. History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
4. Minors in foster care, prisoners, or currently pregnant
5. Suspected child abuse
6. Unable to communicate in English

Primary outcomes:
measure: Change in brain activity
timeFrame: Assessed continuously throughout burn dressing changes (60 minutes) for the fNIRS study period (up to 5 days)
Secondary outcomes:
measure: Procedural pain during burn dressing changes
timeFrame: Assessed within 15 minutes immediately after the burn dressing change about pain experienced during the procedure
measure: Change in procedural anxiety
timeFrame: Assessed at 3 time points (30 minutes prior to procedure, immediately prior to procedure, and within 15 minutes immediately following the procedure) for each dressing change
measure: Self-reported VR experience
timeFrame: Within 15 minutes immediately following burn dressing change when in VR-PAT group
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Henry Xiang, MD, MPH, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: