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NCT06671132 · ClinicalTrials.gov registry record · Phase 2
Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)
A Phase 2 study of Chronic Pain and Low Back Pain, sponsored by Evon Medics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
- 2
- Study locations
NCT06671132 is a Phase 2 study of Chronic Pain and Low Back Pain that is actively recruiting participants, run by Evon Medics. The registered enrollment target is 220 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (72% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06671132, a Phase 2 study of Chronic Pain and Low Back Pain, is actively recruiting participants, sponsored by Evon Medics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- COMBINATION_PRODUCT Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain
- COMBINATION_PRODUCT Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)
Study Locations (2)
District of Columbia
- Howard University - Washington D.C.
Maryland
- Global Pain Management LLC - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2024-10-23 |
| Est. Completion | 2026-01-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06671132
The ClinicalTrials.gov registry entry for NCT06671132 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (72% lower). The listed sponsor is Evon Medics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions - of which Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain is the first listed.
NCT06671132 reports 2 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT06671132 about?
NCT06671132 is a clinical study titled "Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)". 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 Orbitof...
What is the current status of trial NCT06671132?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2024-10-23. Estimated completion is 2026-01-30.
What conditions does trial NCT06671132 study?
This clinical trial studies the following conditions: Chronic Pain, Low Back Pain.
What interventions are being tested in trial NCT06671132?
The interventions under investigation include: Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain (COMBINATION_PRODUCT), Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06671132?
This trial is sponsored by Evon Medics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06671132 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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