Phase II Study of Computerized Chemosensory-Based Orbitofrontal Networks Training CBOT-P for Chronic Low Back Pain Treatment Evaluating Pain Relief, Mood, Cognition, and Brain Structure Changes

What this Trial Is About

Researchers are evaluating a new home-based neuromodulatory platform called Computerized Chemosensory-Based Orbitofrontal Networks Training for Pain CBOT-P in adults with chronic low back pain CLBP. This Phase II randomized clinical trial aims to assess the short- and long-term effects of CBOT-P on pain severity, negative mood, cognitive function, and brain structure, comparing it to a sham device. The study focuses on improving pain and related symptoms while monitoring brain changes over six months. Participants will be randomly assigned to use either the CBOT-P device, which delivers olfactory stimulation with beta-caryophyllene BCP, or a sham CBOT device without the active ingredient. Treatment involves daily use of the assigned device for six months. Brain MRI scans will be taken at the start and after six months to evaluate structural changes. Pain, mood, cognitive abilities, sleep, and physical function will be regularly assessed throughout the study. During the trial, participants will complete assessments at baseline, and at months 1, 3, and 6, including patient-reported pain and mood scales, cognitive tests, and wearable sleep monitoring. Weekly mobile health prompts will encourage participants to report their pain, affect, sleep, and function. The study also collects user experiences to refine the product and aims to support future regulatory approval and commercial availability. The total participation time is six months with ongoing safety monitoring.

Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)