Recruiting
Phase 2

CBOT-P

Sponsor:

Evon Medics LLC

Code:

NCT06671132

Conditions

Chronic Pain

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain

Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)

Study Details

Brief 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

Study ID

NCT06671132

Start date

Oct 23, 2024

Status verified date

Oct, 2024

Completion date

Jan 30, 2026

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBOT-P [CBOT + beta caryophyllene (BCP)]

CBOT device with BCP

sham comparator: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)

CBOT device

Interventions

Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain

CBOT device with beta-caryophyllene

Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)

CBOT device administering continuous olfactoy stimuli with no BCP

Primary outcome measure

  • Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1) [ Time Frame: Baseline to month 1 visit ]
  • Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1) [ Time Frame: Baseline to month 1 visit ]
  • Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1) [ Time Frame: Baseline to month 3 visit ]
  • Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1) [ Time Frame: Baseline to month 3 visit ]
  • Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1) [ Time Frame: Baseline to month 6 visit ]
  • Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1) [ Time Frame: Baseline to month 6 visit ]
  • Grey Matter Volumes of OrbitoFrontal Cortex and Hippocampus Aim 2.2 [ Time Frame: Baseline and 6 months ]

Central Contacts and Locations

Central contacts

Locations

Howard University

Recruiting

Washington, District of Columbia, United States, 20060

Contacts

Global Pain Management LLC

Recruiting

Pasadena, Maryland, United States, 21112

Contacts

More Information

Sponsor

Evon Medics LLC

Last update posted

Nov 4, 2024

Last verified

Oct, 2024

Keywords

  • Chronic pain
  • Pain
  • Negative Affect
  • Cognitive Impairments
  • Attenuation of Structural Brain Loss in CP with high NA
  • PACS outcome
  • Orbitofrontal Cortex
  • Chemosensory-Based Orbitofrontal Networks Training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Evon Medics LLC on 2024-11-04.