Health TrialsbyHealthPanel

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

ConditionsPainVirtual RealityPlaceboTemporomandibular Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-88
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: High impact TMDOther 3 interventions
Group B: Low impact TMDOther 3 interventions

Trial outcomes

Primary outcomes

1

Peak alpha frequency (PAF)

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

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.
2

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)

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.

Secondary outcomes

1

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

Time frame
Daily during the 3-week condition timeframe

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov
Apply now