Viewing Study NCT04851301



Ignite Creation Date: 2024-05-06 @ 4:03 PM
Last Modification Date: 2024-10-26 @ 2:02 PM
Study NCT ID: NCT04851301
Status: RECRUITING
Last Update Posted: 2024-05-23
First Post: 2021-04-06

Brief Title: Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: Virtual reality VR has been seen as an intervention for alleviating clinical chronic and acute pain An approach to pain management utilizing VR presents opportunities for reducing pain and suffering by using immersive aesthetic and multisensory stimulation Investigator will analyze the behavioral and neural mechanisms of active VR against sham VR as two methods that investigate descending pain modulation Thus the central hypothesis is that those who respond to placebos will likely respond to active VR If VR-induced analgesia depends upon the release of endogenous opioids

In this project the investigators will determine the effects of VR at the neural and clinical levels directly for TMD participants inviting participants from an existing Colloca Lab-based cohort phenotyped for diagnosis grade and lowhigh impact pain profiles and prospective TMD participants in collaboration with Johns Hopkins University These participants have agreed to be recontacted for further research Investigator will determine the role of the opioid tone AIM1 In Aim 1 the investigators will determine the role of the endogenous opioid tone for VR-induced hypoalgesia in TMD participants using VR tonic painful stimuli and naloxone given intranasally with established mu-opioid receptor occupancy to determine how the opioid tone shapes VR-induced hypoalgesia

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None