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Behavioural Intervention
Virtual Reality for Chronic Pain (VR TMD EEG Trial)
N/A
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age (18-88 years)
English speaker (written and spoken)
Must not have
Present or past degenerative neuromuscular disease
Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, history of cancer within past 3 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effects of immersive virtual reality to a placebo treatment for chronic pain. The goal is to find new non-medication options for managing pain with low risk.
Who is the study for?
This trial is for individuals experiencing chronic pain, specifically in the jaw joint (TMJ Dysfunction). Participants should be interested in trying non-drug treatments. Details on specific inclusion and exclusion criteria are not provided.
What is being tested?
The study is testing an immersive virtual reality system called RelieVRx against a fake VR treatment (Sham-VR) and no VR at all to understand how they affect chronic pain relief.
What are the potential side effects?
Since this trial involves virtual reality, potential side effects may include dizziness, nausea, eye strain or headaches. However, these are generally low-risk compared to medication side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 88 years old.
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I can speak and write in English.
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I experience some level of chronic pain.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had a muscle-weakening disease.
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I don't have heart, lung, kidney, liver diseases or any cancer in the last 3 years.
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I have neck pain due to nerve issues or narrowing of the spine.
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I have not been hospitalized for a severe psychiatric condition in the last 3 years.
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I am currently taking antipsychotic medication.
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I have hearing problems that are not corrected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective incremental Celsius changes in heat-pain tolerance
Peak alpha frequency (PAF)
Secondary study objectives
Subjective VAS (Visual Analog Scale) scores for mood, situational anxiety, and pain intensity/unpleasantness
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Low impact TMDExperimental Treatment3 Interventions
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
Group II: High impact TMDExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RelieVRx
2023
N/A
~20
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Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
711 Previous Clinical Trials
379,174 Total Patients Enrolled
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