VR-PAT and fNIRS to Identify CNS Biomarkers of Pain

Nationwide Children's Hospital

Status: Begins enrollment in 4 months

Conditions: Pediatric ALL; Burns; Acute Pain; Procedural Pain

Treatments: Other: VR-PAT

Study type: Interventional

Funder types: Other

Identifiers

NCT06303687

STUDY00003496

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

VR-PAT

Experimental group

Description:

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.

Treatment:

Other: VR-PAT

Control

No Intervention group

Description:

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