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

No results posted yet for this study

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

Naloxone

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04851301 on ClinicalTrials.gov