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

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.

Conditions

• Chronic Pain
• Low Back Pain

Interventions

COMBINATION_PRODUCT

Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain

CBOT device with beta-caryophyllene

COMBINATION_PRODUCT

Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)

CBOT device administering continuous olfactoy stimuli with no BCP

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Howard University

  collaborator OTHER

• Global Pain Management, LLC

  collaborator UNKNOWN

• Georgetown University

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Family and Medical Counseling Service, Inc

  collaborator UNKNOWN

• Evon Medics LLC

  lead INDUSTRY

Principal Investigators

• Charles Nwaokobia · Evon Medics LLC

• Evaristus Nwulia, MD, MHS · Evon Medics LLC

• Tanya Alim, MD · Howard University

• Haddi Ogunsola, MD · Global Pain Management, LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-23

Primary Completion

2025-11-30

Completion

2026-01-30

FDA Drug

Yes

Countries

• United States

Study Locations