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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Evon Medics LLC
Study ID
NCT06671132
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Pain
  • Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain — COMBINATION_PRODUCT
    CBOT device with beta-caryophyllene
  • Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) — COMBINATION_PRODUCT
    CBOT device administering continuous olfactoy stimuli with no BCP

Study Details

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.

Key Dates

Start date
Oct 23, 2024
Status verified
Oct 2024
Primary completion
Nov 30, 2025
Completion
Jan 30, 2026

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CBOT-P [CBOT + beta caryophyllene (BCP)]
    CBOT device with BCP
  • Sham Comparator: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)
    CBOT device

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Howard UniversityWashington D.C.District of Columbia20060
Maria Hipolito, MD
[email protected]
202-865-1751
Narayan Rai, MD
[email protected]
202-865-1867
Tanya Alim, MD
Global Pain Management LLCPasadenaMaryland21112
Opeyemi Awofeso, MD
[email protected]
410-891-4007
Vaishnavi Varma, BS
[email protected]
404-991-8424
Haddi Ogunsola, MD

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