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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Ages 18-85.

• Pain duration \> 6 months.

• Must meet the minimum criteria for cognitive function using the PROMIS 4-item cognitive screener \>3.

• Average pain score of \> 5/10, with low back pain being the primary pain site. (5) CLBP (chronic low back pain) meeting Quebec Task Force Classification System Categories I-III.

⁃ (6) Evidence of a prior lumbar spine X-ray to rule out red flags, such as infection, tumor, or fracture.

⁃ (7) For those taking opioids (the opioid subgroup), participants must be prescribed opioids currently for at least 3 consecutive months prior to enrollment. Such patients must be on opioids for a minimum of three months, taking them daily or intermittently during the week. (8) Subject must agree that opioids cannot be increased during the study. (9) No substance use disorder (SUD), except tobacco in the past year based on substance screening survey and frequent urine toxicology screens. (10) No acute suicidality, mania, or psychosis. This will be assessed at study entry, which will also include a review of history in the EHR, Diagnostic Interview for Genetic Studies (DIGS) and Columbia Suicide Severity Rating scale (C-SSRS) and (11) Finally, participants must sign IRB-approved consent.

Locations
United States
Washington, D.c.
Howard University
RECRUITING
Washington D.c.
Maryland
Global Pain Management LLC
RECRUITING
Pasadena
Contact Information
Primary
Evaristus Nwulia, M.D., MHS
enwulia@evonmedics.org
410-227-2005
Backup
Maria Hipolito, MD
mhipolito@howard.edu
571-241-2766
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 220
Treatments
Experimental: CBOT-P [CBOT + beta caryophyllene (BCP)]
CBOT device with BCP
Sham_comparator: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)
CBOT device
Related Therapeutic Areas
Sponsors
Collaborators: Global Pain Management, LLC, Howard University, Georgetown University, University of Maryland, Johns Hopkins University, Family and Medical Counseling Service, Inc, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: Evon Medics LLC

This content was sourced from clinicaltrials.gov