Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT06671132
Status:
RECRUITING
Last Update Posted:
2024-11-04
First Post:
2024-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)
Sponsor:
Evon Medics LLC
Organization:
Study Overview
Official Title:
Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-Pain) Testing Phase
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBOT-P-2
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.
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.
Detailed Description:
The Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P) is a project to develop an effective, scalable, user-friendly, and home-based neuromodulatory platform for broad-spectrum treatment of chronic pain conditions with associated negative affect and cognitive impairments.
The small business, Evon Medics created the olfactory pulsing technology called Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT-P) to enable home-based modulation of the OFC and subcortical limbic structures to treat pain and negative affect. In a stakeholder value canvassing exercise chronic pain (CP) sufferers and pain doctors unanimously desire new non-invasive, home-based, safe, and effective interventions that can reduce pain severity by more than 10%, suggesting that current treatments have limitations. Anterograde and retrograde anatomical tracings have been used to demonstrate direct (monosynaptic) anatomical connection between the OFC and the descending inhibitory pain nodes at the midbrain periaqueductal gray matter (PAG). Transition to CP is marked by weakened modulation of the PAG descending inhibition.
In this study phase, Phase II of this Fast-Track SBIR application, the investigators will conduct a multi-site study of 220 adult patients with CLBP to establish stronger evidence that the product controls pain, reduces negative mood, improves cognition, and protects the brain from shrinking in six months of treatment. Participants in this phase will be randomly assigned in a 1:1 ratio to daily treatment with CBOT-P device (i.e., CBOT with beta-caryophyllene (BCP) compared to a control (Sham) device that looks like the device but does not have the active ingredients and the programmed parameters on the ability to improve pain, mood, cognition and brain functions in chronic pain. Structural magnetic resonance imaging (MRI) will be acquired at baseline and after 6 months of daily treatment with optimized CBOT (based on Phase I) or Sham CBOT device to improve masking. Pain and NA measures, Cognitive batteries, and physical and functional measures will be assessed at baseline, months 1, 3, and 6. Participants would be encouraged through mobile health prompts to complete subjective pain, affect, sleep, and functional studies at the end of each study week. CLBP volunteers, radiologists, and clinicians assessing outcome measures will be blinded to these assignments.
The investigators will also collect user experiences to help refine a final marketable CBOT product, enter the FDA breakthrough designation program for pain that would lead to Medicare/Medicaid reimbursement, engage a wider network of pain stakeholders, and establish marketing for commercial success.
The small business, Evon Medics created the olfactory pulsing technology called Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT-P) to enable home-based modulation of the OFC and subcortical limbic structures to treat pain and negative affect. In a stakeholder value canvassing exercise chronic pain (CP) sufferers and pain doctors unanimously desire new non-invasive, home-based, safe, and effective interventions that can reduce pain severity by more than 10%, suggesting that current treatments have limitations. Anterograde and retrograde anatomical tracings have been used to demonstrate direct (monosynaptic) anatomical connection between the OFC and the descending inhibitory pain nodes at the midbrain periaqueductal gray matter (PAG). Transition to CP is marked by weakened modulation of the PAG descending inhibition.
In this study phase, Phase II of this Fast-Track SBIR application, the investigators will conduct a multi-site study of 220 adult patients with CLBP to establish stronger evidence that the product controls pain, reduces negative mood, improves cognition, and protects the brain from shrinking in six months of treatment. Participants in this phase will be randomly assigned in a 1:1 ratio to daily treatment with CBOT-P device (i.e., CBOT with beta-caryophyllene (BCP) compared to a control (Sham) device that looks like the device but does not have the active ingredients and the programmed parameters on the ability to improve pain, mood, cognition and brain functions in chronic pain. Structural magnetic resonance imaging (MRI) will be acquired at baseline and after 6 months of daily treatment with optimized CBOT (based on Phase I) or Sham CBOT device to improve masking. Pain and NA measures, Cognitive batteries, and physical and functional measures will be assessed at baseline, months 1, 3, and 6. Participants would be encouraged through mobile health prompts to complete subjective pain, affect, sleep, and functional studies at the end of each study week. CLBP volunteers, radiologists, and clinicians assessing outcome measures will be blinded to these assignments.
The investigators will also collect user experiences to help refine a final marketable CBOT product, enter the FDA breakthrough designation program for pain that would lead to Medicare/Medicaid reimbursement, engage a wider network of pain stakeholders, and establish marketing for commercial success.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 4R44NS125745-02 | NIH | None | https://reporter.nih.gov/quic… | View |