RECRUITING

Neural Mechanisms of Immersive Virtual Reality in Chronic Pain

Conditions

Pain Virtual Reality Placebo Temporomandibular Disorder Naloxone Observation TMD volunteers VR

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Neural Mechanisms of Immersive Virtual Reality in Chronic Pain

Quick Facts

Study Start:2021-11-01

Study Completion:2027-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04851301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 88 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion Criteria

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

* 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)

Contacts and Locations

Study Contact

Research Coordinator

CONTACT

410-706-5975

NRSCollocaLab@umaryland.edu

Rachel Massalee, MS

CONTACT

rmassalee@umaryland.edu

Principal Investigator

Luana Colloca, MD/PhD/MS

PRINCIPAL_INVESTIGATOR

University of Maryland Baltimore School of Nursing

Study Locations (Sites)

Luana Colloca

Baltimore, Maryland, 21201-1512

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Luana Colloca, MD/PhD/MS, PRINCIPAL_INVESTIGATOR, University of Maryland Baltimore School of Nursing

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

Study Start Date2021-11-01

Study Completion Date2027-11-30

Study Record Updates

Study Start Date2021-11-01

Study Completion Date2027-11-30

Terms related to this study

Keywords Provided by Researchers

Naloxone
Observation
TMD volunteers
VR

Additional Relevant MeSH Terms

Pain
Virtual Reality
Placebo
Temporomandibular Disorder