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

NCT06214923 | Recruiting DMC FDA Device

• 1 other identifier: HP-00095888 (VR TMD EEG)
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain; Virtual Reality; Placebo; Temporomandibular Disorder

Keywords

TMD volunteers; VR; Clinical Pain; Ecological Momentary Assessment

Outcome Measures

Primary Outcomes (2)

• Peak alpha frequency (PAF)

  EEG response PAF when participants are undergoing the in-person VR

  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.

• Objective incremental Celsius changes in heat-pain tolerance

  Heat pain tolerance to incremental change in temperature will be obtained using a timer (minutes of 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.

Secondary Outcomes (1)

• Subjective VAS (Visual Analog Scale) scores for mood, situational anxiety, and pain intensity/unpleasantness

  Daily during the 3-week condition timeframe

Study Arms (2)

High impact TMD

OTHER

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.

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

Low impact TMD

OTHER

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

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

Interventions

RelieVRx DEVICE

Participants will use RelieVRx daily for 20min/day for 3 weeks

Also known as: Active-VR

High impact TMD; Low impact TMD

Sham-VR DEVICE

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

High impact TMD; Low impact TMD

No-VR (natural history control) OTHER

Participants will continue regular/usual care without any VR devices (goggles or audiovisual input)

High impact TMD; Low impact TMD

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (2)

Luana Colloca

Baltimore, Maryland, 21201-1512, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201-1512, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 30817437 BACKGROUND

• 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.

  PMID: 32345915 BACKGROUND

• 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.

  PMID: 9870976 BACKGROUND

• 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.

  PMID: 30216744 BACKGROUND

MeSH Terms

Conditions

Pain; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Central Study Contacts

Research Coordinator

CONTACT

410-706-5975; NRSCollocaLab@umaryland.edu

Katia Matychak, MS

CONTACT

410-706-5975; katiamatychak@umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the VR and Sham-VR conditions
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a 2 (high- vs. low-impact pain) by 3 (3-week Active VR vs. 3-week Sham VR vs. 3-week NH) conditions mixed experimental design. TMD participants will be clinically phenotype into high-impact or low-impact pain groups according to Graded Chronic Pain Scale (GCPS). All participants will go through Active VR, Sham VR and NH phases (3-week each). 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

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 22, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)