Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
Who is this study for? Patients with Pain, Temporomandibular Disorder
What treatments are being studied? Active Virtual Reality+Naloxone
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 88
Healthy Volunteers: f
View:
• Age (18-88 years)
• English speaker (written and spoken)
• Temporal Mandibular Disorder (TMD) for at least 3 months
Locations
United States
Maryland
Luana Colloca
RECRUITING
Baltimore
Contact Information
Primary
Research Coordinator
NRSCollocaLab@umaryland.edu
410-706-5975
Backup
Rachel Massalee, MS
rmassalee@umaryland.edu
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 259
Treatments
Active_comparator: Naloxone
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.
Sham_comparator: Saline
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.
Other: Natural History
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.
Related Therapeutic Areas
Sponsors
Leads: University of Maryland, Baltimore