Neural Mechanisms of Immersive Virtual Reality in Chronic Pain (VR TMD EEG)
- Conditions
- Temporomandibular DisorderPainVirtual RealityPlacebo
- Interventions
- Device: RelieVRxDevice: Sham-VROther: No-VR (natural history control)
- Registration Number
- NCT06214923
- Lead Sponsor
- University of Maryland, Baltimore
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
- Age (18-88 years)
- English speaker (written and spoken)
- Temporal Mandibular Disorder (TMD) for at least 3 months
- TMD Grade Chronic Pain Scale (GCPS) ≥ 0
- Present or past degenerative neuromuscular disease
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description High impact TMD RelieVRx 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. High impact TMD Sham-VR 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. High impact TMD No-VR (natural history control) 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. Low impact TMD RelieVRx 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 Low impact TMD Sham-VR 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 Low impact TMD No-VR (natural history control) 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
- Primary Outcome Measures
Name Time Method Peak alpha frequency (PAF) 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
Objective incremental Celsius changes in heat-pain tolerance 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)
- Secondary Outcome Measures
Name Time Method Subjective VAS (Visual Analog Scale) scores for mood, situational anxiety, and pain intensity/unpleasantness 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
Trial Locations
- Locations (2)
University of Maryland
🇺🇸Baltimore, Maryland, United States
Luana Colloca
🇺🇸Baltimore, Maryland, United States