Development and Evaluation of Computerized Chemosensory Based Orbitofrontal Networks Training for Treatment of Pain
CompletedPhase 1NCT06218407
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The overarching goal of this study phase, Phase I component is to configure Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) into Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain CBOT-Pain (or CBOT-P) for rapid and sustained reduction of Pain, Negative Affect (NA) and Cognitive Impairments. The investigators aimed at first establishing if stimulation parameters targeting key olfactory regions, and their associated networks, paired with tasks that synergistically activate the orbitofrontal cortex (OFC) would have significantly different acute (\< 7 days) effects in pain and NA intensity reductions. The hypothesis is that the short burst paradigm will more effectively activate the medial OFC and its functional connectivity with medial temporal affective networks, and result in greater reduction of affect and pain severity ratings after 7 days. The investigators will further examine if enhancing the odor regimen with beta-caryophyllene (BCP) content would have more dramatic effects in acute relief of pain, NA, and cognition. Aim 1.1: To optimize CBOT-P stimulation parameters and olfactory stimulants for pain, affect and cognition in CP with and without high NA. This is a 14-day prospective study, in which fMRI and rs-fMRI will be acquired at baseline and day 7 during exposure to short vs long-burst CBOT stimulations. This is followed by daily treatment with short-burst versus long-burst CBOT paradigm over 14 days, during which pain and NA measures will be recorded daily by the subjects, and assessed by train research staff at baseline, day 7 and day 14. Aim 1.2: To determine if CBOT regimen optimized with BCP content produces stronger and faster pain and affective response. This is a 14-day prospective study design, in which daily treatment of CBOT-PLUS (i.e., CBOT with BCP) will be compared against daily treatment with CBOT without BCP enhancement (CBOT). Subjects and clinicians are blinded to the assigned arm…
Study details
- Official title
- Development and Evaluation of Computerized Chemosensory Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)
- Conditions
- Interventions
- Combination product: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) short burst paradigm
- Combination product: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) long burst paradigm
- Combination product: Computerized Chemosensory-Based Orbitofrontal Cortex Training plus beta caryophyllene (CBOT-Plus)
- Combination product: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)
- Sponsor
- Evon Medics LLC
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS); Howard University; Georgetown University
- Start date
- 2023-04-27
- Primary completion
- 2023-09-15
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Ages 18-85. 2. Pain duration \> 6 months. 3. Must meet the minimum criteria for cognitive function using the PROMIS 2-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 surveys 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, Structured Clinical Interview for Psychiatric Disorders (SCID-5) and Columbia Suicide Severity Rating Scale (C-SSRS) and - 11. 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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06218407