RelieVRx
DeviceParticipants will use RelieVRx daily for 20min/day for 3 weeks
Other names: Active-VR
NCT Number: NCT06214923
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.
Interested in participating?
Request Info18 year–88 year
All sexes
Interventional
Not applicable
Luana Colloca, Baltimore, Maryland, 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.
In this study, based on our PAF study and modulation of autonomic measurements via VR, we will determine the role of acute and 3-week VR intervention to help restore PAF oscillations to normal. PAF and autonomic measurements will be collected in TMD participants characterized by low/high-impact pain. All participants will go through Active VR, Sham VR and NH phases (3-week each) where participants will be monitored for changes in cortical excitability via PAF oscillations and clinical benefit via EMA.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will use RelieVRx daily for 20min/day for 3 weeks
Other names: Active-VR
Participants will use Sham-VR, consisting of video, images, and sound in a head-mounted display but lack the "sense of presence" and immersive features of Active-VR (for example, scene changes with head movement). Participants will use the Sham-VR daily for 20min/day for 3 weeks
Participants will continue regular/usual care without any VR devices (goggles or audiovisual input)
Time frame: We will acquire 2-10 min of baseline EEG with open eyes and 2-10 min of EEG with closed eyes. This measurement will occur at each of the four in-person visit approximately every 3 weeks.
EEG response PAF when participants are undergoing the in-person VR
Time frame: The heat incremental changes range from 30 sec to 2 min tolerance. This measurement will occur at each of the four in-person visit approximately every 3 weeks.
Heat pain tolerance to incremental change in temperature will be obtained using a timer (minutes of tolerance)
Time frame: Daily during the 3-week condition timeframe
Participants will take Ecological Momentary Assessment questionnaires. Minimum Value: 0 Maximum Value: 100 Score interpretation: 0=not at all, 100=most/strongest For example, anxiety on a scale of 0-100, 0=no anxiety, 100=the most anxious
Contact information is provided by the study sponsor or research team.
Katia Matychak, MS
CONTACT
Research Coordinator
CONTACT
University of Maryland, Baltimore
Other
Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
Acronym: VR TMD EEG
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