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Immersive Virtual Reality for Chronic Pain
Phase 1 & 2
Recruiting
Led By Luana Colloca, MD/PhD/MS
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
English speaker (written and spoken)
Age (18-88 years)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one session lasting from 2 to 3 hours
Awards & highlights
Study Summary
This trial looks at whether immersive virtual reality can help manage pain better than placebo hypoalgesia (a method of pain management that uses a person's own expectations to help ease pain).
Who is the study for?
This trial is for English-speaking adults aged 18-88 with Temporomandibular Disorder (TMD) for at least 3 months. Excluded are those with certain psychiatric conditions, recent substance abuse, pregnancy, color-blindness, severe facial trauma or motion sickness, and those on specific medications like antidepressants.Check my eligibility
What is being tested?
The study explores how immersive virtual reality can manage chronic pain compared to placebo effects. It involves active VR treatment, sham VR (placebo), no intervention control groups, and the administration of Naloxone or Saline to understand pain mechanisms.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort from wearing a VR headset such as eye strain or nausea due to motion sickness; Naloxone might cause withdrawal symptoms in individuals dependent on opioids.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can speak and write in English.
Select...
I am between 18 and 88 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one session lasting from 2 to 3 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one session lasting from 2 to 3 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ischemic pain endurance
Secondary outcome measures
Ischemic pain rating
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Natural HistoryExperimental Treatment4 Interventions
Natural history group, where participants will not be given any drugs. Participants will be stratified for sex and then randomized to the Natural History group.
Group II: NaloxoneActive Control4 Interventions
NARCAN® Naloxone Nasal Spray will be used to determine how the opioid tone shapes VR-induced hypoalgesia. Participants will be stratified for sex and then randomized to naloxone (The dose of naloxone will be 4 mg, so 0.1 mL of 40 mg/ml naloxone solution given intranasally) or saline (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
Group III: SalinePlacebo Group4 Interventions
Saline group, where participants will be given saline solution (4mg) via an identical spray device. Participants will be stratified for sex and then randomized to saline arm (The dose of saline will be (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active Virtual Reality
2015
N/A
~60
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,397 Total Patients Enrolled
Luana Colloca, MD/PhD/MSPrincipal InvestigatorUniversity of Maryland Baltimore School of Nursing
1 Previous Clinical Trials
182 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any facial injuries in the last 6 weeks.I have had jaw pain or dysfunction for at least 3 months.You have had very bad motion sickness in the past.You have tested positive for illegal drugs like opiates, cocaine, methamphetamines, amphetamines, and THC.You had serious facial injury in the past 3 months.You have struggled with alcohol or drug addiction in the past.I have used prescribed medication for depression, ADHD, pain, or certain sedatives in the last 3 months.You have difficulty seeing certain colors.You have had angioedema in the past.I have or had a muscle-weakening disease.I don't have any conditions that would prevent wearing a VR mask.I have a history of fainting.I have had jaw or temple pain from a toothache or infection in the last 3 months.I have hearing problems that haven't been corrected.You or your close family member has a history of severe mental illness like schizophrenia.I have not been hospitalized for a severe psychiatric condition in the last 3 years.My neck pain is not due to TMD but another condition like stenosis.I have high blood pressure or symptoms of low blood pressure.I don't have heart, lung, kidney, liver diseases, or any cancer in the last 3 years.I can speak and write in English.I am between 18 and 88 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Natural History
- Group 2: Naloxone
- Group 3: Saline
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Temporomandibular Joint Disorder Patient Testimony for trial: Trial Name: NCT04851301 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigational trial open to elderly individuals who are over eighty years old?
"Per the trial's requirements, eligible participants must be at least 18 years old and no more than 88."
Answered by AI
Are there any slots available for individuals to join this clinical trial?
"Affirmative. Clinicaltrials.gov verifies that this research is currently recruiting patients, with the initial posting date of November 1st 2021 and a recent update on April 26th 2022. A total 259 participants will be accepted from one trial site."
Answered by AI
Is participation in this research available to me?
"This clinical trial is inviting 259 participants who have taken placebos and are between 18 and 88 years of age."
Answered by AI
To what maladies is the medication Naloxone typically utilized for?
"Naloxone is renowned for its use in treating opioid dependence. It is also prescribed to palliate pain, pruritus, and septic shock."
Answered by AI
Has Naloxone been trialed in other medical procedures?
"Currently, 37 active clinical trials are assessing the safety and efficacy of Naloxone. Nine of these studies have reached Phase 3, with most being conducted in Durham, North carolina; however many other sites across America are also running similar experiments."
Answered by AI
What is the overall scope of participation for this research project?
"Correct. According to information posted on clinicaltrials.gov, this medical experiment is currently recruiting patients, with the initial post being made on November 1st 2021 and most recent update occurring April 26th 2022. The study requires 259 participants from at least one medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
Luana Colloca
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
What questions have other patients asked about this trial?
How often would I need to come to Baltimore? I go to a pain management doctor--do I have to stop that?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I want help with this bad jaw pain. I need relief from this pain. I don't know what to do.
PatientReceived 1 prior treatment
I've learned to manage my pain; however, it's never-ending. All my activities revolve around how I'm feeling that day. If I throw caution to the wind and do what I want, my body pays for it for the next several days or longer. I happened to see this, and I'm not sure what it entails, but it looked interesting and something I haven't tried. Anything that gives me hope that I can go on a long plane ride to a vacation and still be able to enjoy the vacation after, I may try.
PatientReceived no prior treatments
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