VR-PAT and FNIRS to Identify CNS Biomarkers of Pain

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06303687
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nationwide Children's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Henry Xiang, MD, MPH, PhD, MBA
Principal Investigator Affiliation Nationwide Children's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Acute Pain, Pediatric ALL, Procedural Pain, Burns
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

No Intervention: Control

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

Interventions

Other: - VR-PAT

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Nationwide Children's Hospital, Columbus 4509177, Ohio 5165418

Status

Address

Nationwide Children's Hospital

Columbus 4509177, Ohio 5165418, 43205

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