Luana Colloca
Baltimore, Maryland, 21201-1512, United States
NCT Number: NCT04851301
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.
This study is active but is not currently recruiting participants.
18 year–88 year
All sexes
Interventional
Phase 1 / Phase 2
Baltimore, Maryland, 21201-1512, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be assigned to an immersive VR environment.
Other names: Active VR
Participants will be assigned to a sham VR environment without the immersive experience.
Other names: Sham VR
Participants will experience tonic pain tolerance tests without exposure to any environments.
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
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
Participants will not be provided Naloxone or Saline.
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)
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
University of Maryland, Baltimore
Other
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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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