Neural Mechanisms of Immersive Virtual Reality in Chronic Pain

Phase 2Active Not RecruitingNCT04851301

University of Maryland, Baltimore259 enrolled

Overview

This project examines, in chronic pain, the mechanisms of immersive virtual reality compared to the mechanisms of placebo hypoalgesia. The potential of developing new non-pharmacological premises for low-risk interventions for pain management is high.

Virtual reality (VR) has been seen as an intervention for alleviating clinical chronic (and acute) pain. An approach to pain management utilizing VR presents opportunities for reducing pain and suffering by using immersive, aesthetic, and multisensory stimulation. Investigator will analyze the behavioral and neural mechanisms of active VR against sham VR as two methods that investigate descending pain modulation. Thus, the central hypothesis is that those who respond to placebos will likely respond to active VR. If VR-induced analgesia depends upon the release of endogenous opioids. In this project, the investigators will determine the effects of VR at the neural and clinical levels directly for TMD participants, inviting participants from an existing Colloca Lab-based cohort phenotyped for diagnosis, grade, and low/high impact pain profiles and prospective TMD participants in collaboration with Johns Hopkins University. These participants have agreed to be recontacted for further research. Investigator will determine the role of the opioid tone (AIM1). In Aim 1, the investigators will determine the role of the endogenous opioid tone for VR-induced hypoalgesia in TMD participants using VR, tonic painful stimuli, and naloxone given intranasally with established mu-opioid receptor occupancy to determine how the opioid tone shapes VR-induced hypoalgesia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

259

Conditions

Pain Virtual Reality Placebo Temporomandibular Disorder

Interventions

Active Virtual RealityBEHAVIORAL

Participants will be assigned to an immersive VR environment.

sham Virtual RealityBEHAVIORAL

Participants will be assigned to a sham VR environment without the immersive experience.

No InterventionOTHER

Participants will experience tonic pain tolerance tests without exposure to any environments.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 88 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age (18-88 years) * English speaker (written and spoken) * Temporal Mandibular Disorder (TMD) for at least 3 months Exclusion Criteria: * Present or past degenerative neuromuscular disease * Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, history of cancer within past 3 years * Cervical pain other than TMD related (e.g. stenosis, radiculopathy) * Any personal (or family first degree) history of mania, schizophrenia, or other psychoses * Severe psychiatric condition (e.g., schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years. * Use of antidepressants, ADHD medication, non-over-the-counter painkillers, methadone, benzodiazepines, barbiturates, and/or narcotics during the past 3 months * Lifetime alcohol/drug dependence or alcohol/drug abuse in the past 3 months * Pregnancy or breastfeeding * Color-blindness * Pain in jaw or temple in last 3 months due to toothache or infection * Any facial trauma that has occurred in the last 6 weeks * History of severe facial trauma in the last 3 months * Impaired or uncorrected hearing * Conditions that would interfere with the VR mask placement (e.g. trauma, burn, infection) * Known history of severe motion sickness * High blood pressure or symptomatic low blood pressure * History of fainting * History of angioedema * Failed drug test (testing for opiates, cocaine, methamphetamines, amphetamines, and THC)

Locations (1)

Luana Colloca

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Ischemic pain endurance

Increments in experimental ischemic pain endurance will be assessed using a timer (minutes of tolerance)

Time frame: one session lasting from 2 to 3 hours

Secondary Outcomes

Ischemic pain rating

Increments in experimental ischemic pain endurance will be assessed using Visual Analogue Scale (VAS) (self-reported numbers) anchored from 0=no pain to 100=maximum tolerable pain. The VAS will be used every 10 seconds during the ischemic pain endurance task

Time frame: one session lasting from 2 to 3 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.