Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
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 Start (Actual) 1 November 2021
🗓️ Primary Completion (Estimated) 31 October 2027
✅ Study Completion (Estimated) 30 November 2027
👥 Enrollment (Estimated) 259
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age (18-88 years)
    • * English speaker (written and spoken)
    • * Temporal Mandibular Disorder (TMD) for at least 3 months

    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 other than TMD related (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 antidepressants, ADHD medication, non-over-the-counter painkillers, methadone, benzodiazepines, barbiturates, and/or narcotics during the past 3 months
    • * Lifetime alcohol/drug dependence or alcohol/drug abuse in the past 3 months
    • * Pregnancy or breastfeeding
    • * Color-blindness
    • * Pain in jaw or temple in last 3 months due to toothache or infection
    • * Any facial trauma that has occurred in the last 6 weeks
    • * History of severe facial trauma in the last 3 months
    • * Impaired or uncorrected hearing
    • * Conditions that would interfere with the VR mask placement (e.g. trauma, burn, infection)
    • * Known history of severe motion sickness
    • * High blood pressure or symptomatic low blood pressure
    • * History of fainting
    • * History of angioedema
    • * Failed drug test (testing for opiates, cocaine, methamphetamines, amphetamines, and THC)
Ages Eligible for Study: 18 Years to 88 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 April 2021
  • First Submitted that Met QC Criteria 14 April 2021
  • First Posted 20 April 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 May 2024
  • Last Update Posted 23 May 2024
  • Last Verified May 2024