Neural Mechanisms of Immersive Virtual Reality in Chronic Pain

University of Maryland Baltimore (UMB)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Temporomandibular Disorder; Pain; Virtual Reality; Placebo

Treatments: Drug: Naloxone; Other: No Intervention; Behavioral: Active Virtual Reality; Other: Saline; Behavioral: sham Virtual Reality; Other: Natural history

Study type: Interventional

Funder types: Other

Identifiers

NCT04851301

HP-00095888

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 259 estimated patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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259 participants in 3 patient groups

Naloxone

Active Comparator group

Description:

NARCAN® Naloxone Nasal Spray will be used to determine how the opioid tone shapes VR-induced hypoalgesia. Participants will be stratified for sex and then randomized to naloxone (The dose of naloxone will be 4 mg, so 0.1 mL of 40 mg/ml naloxone solution given intranasally) or saline (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.

Treatment:

Behavioral: sham Virtual Reality

Other: No Intervention

Behavioral: Active Virtual Reality

Drug: Naloxone

Saline

Sham Comparator group

Description:

Saline group, where participants will be given saline solution (4mg) via an identical spray device. Participants will be stratified for sex and then randomized to saline arm (The dose of saline will be (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.

Treatment:

Behavioral: sham Virtual Reality

Other: Saline

Other: No Intervention

Behavioral: Active Virtual Reality

Natural History

Other group

Description:

Natural history group, where participants will not be given any drugs. Participants will be stratified for sex and then randomized to the Natural History group.

Treatment:

Other: Natural history

Behavioral: sham Virtual Reality

Other: No Intervention

Behavioral: Active Virtual Reality