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OpenTrials
Active, Not Recruiting

NCT Number: NCT04851301

Neural Mechanisms of Immersive Virtual Reality in Chronic Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Luana Colloca

Baltimore, Maryland, 21201-1512, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Active Virtual Reality

Behavioral

Participants will be assigned to an immersive VR environment.

Other names: Active VR

sham Virtual Reality

Behavioral

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

Other names: Sham VR

No intervention

Other

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

naloxone

Drug

4mg of Naloxone will be administered (0.1 mL of 40 mg/ml naloxone solution given intranasally).

A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment.

Other names: Naloxone Hydrochloride/Narcan Intranasal

Saline

Other

Intranasal Normal Saline (0.1 mL 0.9% sodium chloride) will be administered shortly before beginning the fMRI experiment.

A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment.

Other names: Placebo, Sodium chloride

Natural History

Other

Participants will not be provided Naloxone or Saline.

Primary outcomes

  1. Ischemic pain endurance

    Time frame: one session lasting from 2 to 3 hours

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

Secondary outcomes

  1. Ischemic pain rating

    Time frame: one session lasting from 2 to 3 hours

    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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 20, 2021
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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