Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
NCT ID: NCT04851301
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
259 participants
INTERVENTIONAL
2021-11-01
2026-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Naloxone
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.
Active Virtual Reality
Participants will be assigned to an immersive VR environment.
sham Virtual Reality
Participants will be assigned to a sham VR environment without the immersive experience.
No Intervention
Participants will experience tonic pain tolerance tests without exposure to any environments.
Naloxone
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.
Saline
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.
Active Virtual Reality
Participants will be assigned to an immersive VR environment.
sham Virtual Reality
Participants will be assigned to a sham VR environment without the immersive experience.
No Intervention
Participants will experience tonic pain tolerance tests without exposure to any environments.
Saline
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.
Natural History
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.
Active Virtual Reality
Participants will be assigned to an immersive VR environment.
sham Virtual Reality
Participants will be assigned to a sham VR environment without the immersive experience.
No Intervention
Participants will experience tonic pain tolerance tests without exposure to any environments.
Natural history
Participants will not be provided Naloxone or Saline.
Interventions
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Active Virtual Reality
Participants will be assigned to an immersive VR environment.
sham Virtual Reality
Participants will be assigned to a sham VR environment without the immersive experience.
No Intervention
Participants will experience tonic pain tolerance tests without exposure to any environments.
Naloxone
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.
Saline
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.
Natural history
Participants will not be provided Naloxone or Saline.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* English speaker (written and spoken)
* Temporal Mandibular Disorder (TMD) for at least 3 months
Exclusion Criteria
* 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)
18 Years
88 Years
ALL
No
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Luana Colloca
Professor
Principal Investigators
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Luana Colloca, MD/PhD/MS
Role: PRINCIPAL_INVESTIGATOR
University of Maryland Baltimore School of Nursing
Locations
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Luana Colloca
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Honzel E, Murthi S, Brawn-Cinani B, Colloca G, Kier C, Varshney A, Colloca L. Virtual reality, music, and pain: developing the premise for an interdisciplinary approach to pain management. Pain. 2019 Sep;160(9):1909-1919. doi: 10.1097/j.pain.0000000000001539. No abstract available.
Colloca L, Raghuraman N, Wang Y, Akintola T, Brawn-Cinani B, Colloca G, Kier C, Varshney A, Murthi S. Virtual reality: physiological and behavioral mechanisms to increase individual pain tolerance limits. Pain. 2020 Sep 1;161(9):2010-2021. doi: 10.1097/j.pain.0000000000001900.
Colloca L. The Placebo Effect in Pain Therapies. Annu Rev Pharmacol Toxicol. 2019 Jan 6;59:191-211. doi: 10.1146/annurev-pharmtox-010818-021542. Epub 2018 Sep 14.
Amanzio M, Benedetti F. Neuropharmacological dissection of placebo analgesia: expectation-activated opioid systems versus conditioning-activated specific subsystems. J Neurosci. 1999 Jan 1;19(1):484-94. doi: 10.1523/JNEUROSCI.19-01-00484.1999.
Other Identifiers
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HP-00095888
Identifier Type: -
Identifier Source: org_study_id
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