Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
NCT04851301 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 259
Last updated 2026-02-27
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.
Conditions
- Pain
- Virtual Reality
- Placebo
- Temporomandibular Disorder
Interventions
- BEHAVIORAL
-
Active Virtual Reality
Participants will be assigned to an immersive VR environment.
- BEHAVIORAL
-
sham Virtual Reality
Participants will be assigned to a sham VR environment without the immersive experience.
- OTHER
-
No Intervention
Participants will experience tonic pain tolerance tests without exposure to any environments.
- DRUG
-
4mg of Naloxone will be administered (0.1 mL of 40 mg/ml naloxone solution given intranasally). A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment.
- OTHER
-
Saline
Intranasal Normal Saline (0.1 mL 0.9% sodium chloride) will be administered shortly before beginning the fMRI experiment. A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment.
- OTHER
-
Natural history
Participants will not be provided Naloxone or Saline.
Sponsors & Collaborators
-
University of Maryland, Baltimore
lead OTHER
Principal Investigators
-
Luana Colloca, MD/PhD/MS · University of Maryland Baltimore School of Nursing
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 88 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-01
- Primary Completion
- 2025-12-30
- Completion
- 2026-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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