Clinical trial NCT06854991: Healthy Children and Virtual Reality Mediation of Simulated Pain
Official title: Neuroimaging Biomarkers for Assessing Brain Mechanisms Mediating Virtual Reality Anxiety and Pain Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Pain
Experimental Pain in Healthy Human Participants
Children
Adolescents
Keywords: Acute Pain
Experimental Pain
Virtual Reality
fNIRS
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will start with a control condition (no distraction tool) and will then receive an Active VR, Passive VR, and iPad game distraction in random order during their experimental pain/fNIRS session.
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in brain activation picked up on fNIRS between the active VR, passive VR, iPad game, and control conditions
timeFrame: Assessed continuously throughout the simulated pain session (60 minutes) for one visit
Secondary outcomes:
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: