Neural Mechanisms of Immersive Virtual Reality in Chronic Pain (VR TMD EEG)
NCT ID: NCT06214923
Last Updated: 2026-01-26
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
NA
78 participants
INTERVENTIONAL
2024-04-09
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.
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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
There will be 4 in-person visits where participants will be monitored for changes in cortical excitability via PAF oscillations and clinical benefit via Ecological Momentary Assessments (EMA) during the 3-week conditions.
Crossover Study Model was chosen because each participant will receive VR, Sham-VR, and No-VR in random order
BASIC_SCIENCE
SINGLE
Study Groups
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Low impact TMD
Other: TMD Phenotype
TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 0, 1, and 2a
RelieVRx
Participants will use RelieVRx daily for 20min/day for 3 weeks
Sham-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
No-VR (natural history control)
Participants will continue regular/usual care without any VR devices (goggles or audiovisual input)
High impact TMD
Other: TMD Phenotype
TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 2b, 3, and 4.
RelieVRx
Participants will use RelieVRx daily for 20min/day for 3 weeks
Sham-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
No-VR (natural history control)
Participants will continue regular/usual care without any VR devices (goggles or audiovisual input)
Interventions
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RelieVRx
Participants will use RelieVRx daily for 20min/day for 3 weeks
Sham-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
No-VR (natural history control)
Participants will continue regular/usual care without any VR devices (goggles or audiovisual input)
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
* TMD Grade Chronic Pain Scale (GCPS) ≥ 0
Exclusion Criteria
* Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, history of cancer within past 3 years
* Cervical pain (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 Antipsychotics (e.g., Risperdal, Ability and clozaril)Lifetime alcohol/drug dependence or alcohol/drug abuse in past 3 months
* Pregnancy or breast feeding
* Color-blindness
* Impaired or uncorrected hearing
* Non-dominant hand
* Any facial trauma that has occurred in the last 6 weeks
* History of a severe facial trauma in the last 2-3 months
* Conditions that would interfere with the VR mask placement (e.g. trauma, burn, infection)
* Known history of severe motion sickness
* Non-removable head cover, artificial hair, certain types of braids or dreadlocks
* History of fainting
* History of angioedema
* Failed drug test (testing for opiates, cocaine, methamphetamines, and amphetamines)
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
Locations
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Luana Colloca
Baltimore, Maryland, United States
University of Maryland
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.
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.
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.
Other Identifiers
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HP-00095888 (VR TMD EEG)
Identifier Type: -
Identifier Source: org_study_id
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