Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)
Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-Pain) Testing Phase
Evon Medics LLC
220 participants
Oct 23, 2024
INTERVENTIONAL
Conditions
Summary
The overarching goal of this study phase, Phase II component is to perform a randomized clinical trial of the refined Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain \[CBOT-Pain (or CBOT-P)\] from Phase I, compared to sham Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) in Chronic Low Back Pain (CLBP) to determine its short- and long-term effectiveness on Pain, Negative Affect (NA), Cognition and Cortical Brain Structure (PACS), long-term safety, and indications. The investigators will perform a randomized clinical trial of the refined CBOT-P from Phase I, compared to sham CBOT in CLBP. Aim 2.1: To determine if CBOT-P significantly influences: (1) acute and long-term reduction of pain severity, and (2) acute and long-term reduction of negative affect. The hypothesis is that optimized CBOT will produce faster, stronger, and longer-lasting improvements in pain severity, NA severity, cognitive impairments, and sleep and functional outcomes. Aim 2.2 To determine if CBOT-P significantly prevents or reduces progressive shrinkage in the orbitofrontal cortex (OFC), cingulate cortex, and hippocampus. MRI will be acquired at baseline and 6th month. An integrative analysis will be conducted to determine the link between changes in brain structure and cognitive trajectory. The hypothesis is that the CBOT optimized with BCP significantly attenuates shrinkage in OFC and other prefrontal cortex (PFC) regions, compared to the Sham intervention.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
CBOT device with beta-caryophyllene
CBOT device administering continuous olfactoy stimuli with no BCP
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06671132