VR-PAT and fNIRS to Identify CNS Biomarkers of Pain

NCT ID: NCT06303687

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-31

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Acute Pain Pediatric ALL Procedural Pain Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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VR-PAT

Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game while also wearing the fNIRS, during their clinically scheduled burn dressing change.

Group Type EXPERIMENTAL

VR-PAT

Intervention Type OTHER

Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device

Control

Participant wears the fNIRS and can engage in standard distraction techniques, during their clinically scheduled burn dressing change.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VR-PAT

Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device

Intervention Type OTHER

Other Intervention Names

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Virtual Reality

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Henry Xiang

Professor of Medicine and Center Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henry Xiang, MD, MPH, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Central Contacts

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Henry Xiang, MD, MPH, PhD, MBA

Role: CONTACT

614-355-5893

Other Identifiers

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STUDY00003496

Identifier Type: -

Identifier Source: org_study_id

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