Measuring brain oxygen levels in chronic pain patients using spinal cord stimulation
A Prospective, Observational Study Examining Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
This study is testing how spinal cord stimulation affects brain oxygen levels in people with chronic pain to see if there's a connection between brain activity and their pain experience.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CereVu Medical, Inc. Industry-sponsored |
| Locations | 1 site (Walnut Creek, California) |
| Trial ID | NCT06559735 on ClinicalTrials.gov |
What this trial studies
This study aims to assess changes in cerebral blood oxygenation and flow in patients with chronic pain undergoing spinal cord stimulation (SCS). Using the CereVu sensor and ROPA system, objective measurements of cerebral nociceptive hemodynamic responses will be collected before, during, and after the SCS procedure. These measurements will be analyzed alongside subjective pain reports to understand their correlation. The study seeks to develop proprietary algorithms for better analysis of these responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic, intractable pain that has not responded to conservative treatments for at least six months.
Not a fit: Patients who are pregnant, nursing, or have other medical conditions that interfere with the study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for chronic pain patients.
How similar studies have performed: While similar approaches have been explored, this specific methodology utilizing the CereVu sensor is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be 18 years of age or older at the time of enrolment 2. Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months 3. Subject has a minimum Visual Analog Scale (VAS) score of 50 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline or a 5 on a Numerical Rating Scale (NRS) 4. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician 5. Be willing and capable of giving informed consent 6. Be willing and able to comply with study-related requirements, procedures, and visits Exclusion Criteria: 1. Subject is pregnant or nursing 2. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator 3. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes 4. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS) 5. Have prior experience with SCS 6. Be concomitantly participating in another clinical study 7. Subject has secondary gain issues that could interfere with the study measures or outcomes 8. Subject is contraindicated for use of non-invasive cerebral oxygenation measurements (e.g., at risk for sensor displacement such as facial cosmetic. Non-intact skin on the forehead, or ENT surgery) 9. Subject is allergic to any adhesives, materials or fluids in or used in conjunction with the CereVu sensor
Where this trial is running
Walnut Creek, California
- Boomerang Healthcare — Walnut Creek, California, United States (Recruiting)
Study contacts
- Study coordinator: Jon Gasson
- Email: jgasson@cerevu.com
- Phone: 415-233-2119
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.