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RECRUITING

NCT06671132

PHASE2

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

Sponsor: Evon Medics LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2024-10-23

Completion Date

2026-01-30

Last Updated

2024-11-04

Healthy Volunteers

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

Inclusion Criteria: 1. Ages 18-85. 2. Pain duration \> 6 months. 3. Must meet the minimum criteria for cognitive function using the PROMIS 4-item cognitive screener \>3. 4. 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. Exclusion Criteria: 1. Back surgery within the past six months. 2. Active worker's compensation or litigation claims. 3. New pain and/or psychiatric treatments within 2 weeks of enrollment. 4. Intent to add new or increase pain treatments during the study period, such as back surgery, nerve block procedures, or medications. 5. Intent to add new psychiatric treatments during the first 3 months of the study. 6. Any clinically unstable systemic illness that is judged to interfere with the trial. 7. History of cardiac, nervous system, or respiratory disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for respiratory depression. 8. Non-ambulatory status. 9. Pregnancy or the intent to become pregnant during the study. Women of childbearing age will have urine pregnancy testing at enrollment and monthly. (10) Anosmia or significant nasal disease (11) Contraindications to MRI (12) Stroke or TBI (traumatic brain injury).

Locations (2)

Howard University

Washington D.C., District of Columbia, United States

Global Pain Management LLC

Pasadena, Maryland, United States