Neural Mechanisms of Immersive Virtual Reality in Chronic Pain (VR TMD EEG)

University of Maryland Baltimore (UMB)

Status: Enrolling

Conditions: Temporomandibular Disorder; Pain; Virtual Reality; Placebo

Treatments: Other: No-VR (natural history control); Device: Sham-VR; Device: RelieVRx

Study type: Interventional

Funder types: Other

Identifiers

NCT06214923

HP-00095888 (VR TMD EEG)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

78 participants in 2 patient groups

High impact TMD

Other group

Description:

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.

Treatment:

Device: RelieVRx

Device: Sham-VR

Other: No-VR (natural history control)

Low impact TMD

Other group

Description:

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

Treatment:

Device: RelieVRx

Device: Sham-VR

Other: No-VR (natural history control)