Recruiting

VR TMD

Sponsor:

University of Maryland, Baltimore

Code:

NCT06214923

Conditions

Pain

Virtual Reality

Placebo

Temporomandibular Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RelieVRx

Sham-VR

No-VR (natural history control)

Study Details

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

Study ID

NCT06214923

Start date

Apr 9, 2024

Status verified date

Jul, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

May 30, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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

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

No-VR (natural history control)

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

Primary outcome measure

  • Peak alpha frequency (PAF) [ Time Frame: 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 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Research Coordinator

410-706-5975NRSCollocaLab@umaryland.edu

Katia Matychak, MS

410-706-5975katiamatychak@umaryland.edu

Locations

Luana Colloca

Recruiting

Baltimore, Maryland, United States, 21201-1512

Contacts

Luana Colloca, MD,PhD,MS

3013648089Colloca@umaryland.edu

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201-1512

Contacts

Luana Colloca, MD, PhD, MS

3013648089colloca@umaryland.edu

Katia Matychak, MS

4107065975asuhr@umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • TMD volunteers
  • VR
  • Clinical Pain
  • Ecological Momentary Assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-07.