Viewing Study NCT06214923



Ignite Creation Date: 2024-05-06 @ 8:00 PM
Last Modification Date: 2024-10-26 @ 3:18 PM
Study NCT ID: NCT06214923
Status: RECRUITING
Last Update Posted: 2024-06-06
First Post: 2023-12-18

Brief Title: Neural Mechanisms of Immersive Virtual Reality in Chronic Pain VR TMD EEG
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: 2024-06
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: VR TMD EEG
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

In this study based on our PAF study and modulation of autonomic measurements via VR we will determine the role of acute and 3-week VR intervention to help restore PAF oscillations to normal PAF and autonomic measurements will be collected in TMD participants characterized by lowhigh-impact pain All participants will go through Active VR Sham VR and NH phases 3-week each where participants will be monitored for changes in cortical excitability via PAF oscillations and clinical benefit via EMA

Study Oversight

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