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New treatment option for Chronic Pain
Official title Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)
ClinicalTrials.gov ID: NCT06671132
What this study is testing
What is Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain?
Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain is an investigational medicine, given as an once-daily, being studied as a potential treatment for chronic pain.
Also referred to as CBOT-P, CBOT device with BCP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Ages 18-85.
- Pain duration \> 6 months.
- Must meet the minimum criteria for cognitive function using the PROMIS 4-item cognitive screener \>3.
- 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...
You likely can't join if
- 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.
See the full eligibility criteria
- Ages 18-85.
- Pain duration \> 6 months.
- Must meet the minimum criteria for cognitive function using the PROMIS 4-item cognitive screener \>3.
- 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...
- 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. (10) Anosmia or significant nasal disease (11) Contraindications to MRI...
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Pasadena, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Pasadena, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.