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

Pain Clinical Trial

— VR TMD EEG  

Official title:

Neural Mechanisms of Immersive Virtual Reality in Chronic Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06214923
• Other study ID #: HP-00095888 (VR TMD EEG)
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: September 2026

Study information

• Verified date: March 2024
• Source: University of Maryland, Baltimore
• Contact: Research Coordinator
• Phone: 410-706-5975
• Email: NRSCollocaLab[@]umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: September 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Pain
• Placebo
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Virtual Reality

Intervention

Device:
• 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

Other:
• No-VR (natural history control)
Participants will continue regular/usual care without any VR devices (goggles or audiovisual input)

Locations

Country	Name	City	State
United States	Luana Colloca	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Subjective VAS (Visual Analog Scale) scores for mood, situational anxiety, and pain intensity/unpleasantness	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	Daily during the 3-week condition timeframe