Status:
RECRUITING
Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
Lead Sponsor:
CereVu Medical, Inc.
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of the study is to determine changes in cerebral nociceptive hemodynamic response (blood oxygenation/flow) before, during and following spinal cord stimulation (SCS). Objective m...
Eligibility Criteria
Inclusion
- Be 18 years of age or older at the time of enrolment
- Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months
- 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)
- Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- Be willing and capable of giving informed consent
- Be willing and able to comply with study-related requirements, procedures, and visits
Exclusion
- Subject is pregnant or nursing
- 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
- 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
- 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)
- Have prior experience with SCS
- Be concomitantly participating in another clinical study
- Subject has secondary gain issues that could interfere with the study measures or outcomes
- 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)
- Subject is allergic to any adhesives, materials or fluids in or used in conjunction with the CereVu sensor
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06559735
Start Date
August 13 2024
End Date
March 31 2025
Last Update
August 19 2024
Active Locations (1)
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1
Boomerang Healthcare
Walnut Creek, California, United States, 94598