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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06214923
Status
Recruiting
Apply to this trial

Conditions

  • Pain
  • Placebo
  • Temporomandibular Disorder
  • Virtual Reality

Eligibility Criteria

Sex
ALL
Age
18 Years - 88 Years
Healthy Volunteers
Not accepted

Interventions

  • RelieVRx — DEVICE
    Participants will use RelieVRx daily for 20min/day for 3 weeks
  • 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
  • No-VR (natural history control) — OTHER
    Participants will continue regular/usual care without any VR devices (goggles or audiovisual input)

Study Details

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.

Key Dates

Start date
Apr 9, 2024
Status verified
Jan 2026
Primary completion
May 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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

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. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Luana CollocaBaltimoreMaryland21201-1512
Luana Colloca, MD,PhD,MS
[email protected]
301-364-8089
University of MarylandBaltimoreMaryland21201-1512
Luana Colloca, MD, PhD, MS
[email protected]
301-364-8089
Katia Matychak, MS
[email protected]
4107065975

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By research site
Luana Colloca· Baltimore, MDUniversity of Maryland· Baltimore, MD

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