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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 88 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06214923
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Maryland, Baltimore
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pain, Virtual Reality, Placebo, Temporomandibular Disorder
Additional Details

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.

Arms & Interventions

Arms

Other: 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.

Other: 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

Interventions

Device: - RelieVRx

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

Device: - 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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Luana Colloca, Baltimore, Maryland

Status

Address

Luana Colloca

Baltimore, Maryland, 21201-1512

University of Maryland, Baltimore, Maryland

Status

Address

University of Maryland

Baltimore, Maryland, 21201-1512

Site Contact

Luana Colloca, MD, PhD, MS

[email protected]

301-364-8089