Status:
COMPLETED
Development and Evaluation of Computerized Chemosensory Based Orbitofrontal Networks Training for Treatment of Pain
Lead Sponsor:
Evon Medics LLC
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Howard University
Conditions:
Chronic Pain
Low Back Pain
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
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 Ne...
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...
Eligibility Criteria
Inclusion
- Ages 18-85.
- Pain duration \> 6 months.
- Must meet the minimum criteria for cognitive function using the PROMIS 2-item cognitive screener \>3.
- Average pain score of \> 5/10, with low back pain being the primary pain site.
- CLBP (chronic low back pain) meeting Quebec Task Force Classification System Categories I-III.
- Evidence of a prior lumbar spine X-ray to rule out red flags, such as infection, tumor, or fracture.
- 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.
- Subject must agree that opioids cannot be increased during the study.
- No substance use disorder (SUD), except tobacco, in the past year based on substance screening surveys and frequent urine toxicology screens.
- 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 -
- Participants must sign IRB-approved consent.
Exclusion
- Back surgery within the past six months.
- Active worker's compensation or litigation claims.
- New pain and/or psychiatric treatments within 2 weeks of enrollment.
- Intent to add new or increase pain treatments during the study period, such as back surgery, nerve block procedures, or medications.
- Intent to add new psychiatric treatments during the first 3 months of the study.
- Any clinically unstable systemic illness that is judged to interfere with the trial.
- 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.
- Non-ambulatory status.
- Pregnancy or the intent to become pregnant during the study. Women of childbearing age will have urine pregnancy testing at enrollment and monthly.
- Anosmia or significant nasal disease
- Contraindications to MRI
- Stroke or TBI (traumatic brain injury).
Key Trial Info
Start Date :
April 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2023
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06218407
Start Date
April 27 2023
End Date
September 15 2023
Last Update
January 23 2024
Active Locations (1)
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1
Howard University
Washington D.C., District of Columbia, United States, 20060