Actively Recruiting
Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
Led by CereVu Medical, Inc. · Updated on 2024-08-19
25
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 measurements of cerebral nociceptive hemodynamic responses will be obtained with the CereVu sensor and ROPA system and will be analyzed offline and compared against subjective measures of pain. Proprietary analysis algorithms will be incorporated and developed to understand how the objective measurements correlate with subject reported pain levels
CONDITIONS
Official Title
Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older at the time of enrolment
- Diagnosed with chronic, intractable pain of the trunk and/or limbs, refractory to conservative therapy for at least 6 months
- Have a Visual Analog Scale (VAS) score of 50 mm or higher or a Numerical Rating Scale (NRS) score of 5 or higher at baseline
- Be an appropriate candidate for the required surgical procedures based on clinical judgment
- Be willing and capable of giving informed consent
- Be willing and able to comply with study procedures and visits
You will not qualify if you...
- Currently pregnant or nursing
- Have medical conditions or pain in areas not treated with spinal cord stimulation that could interfere with the study
- Have an active psychological or psychiatric disorder affecting pain perception or compliance
- Have an existing drug pump, spinal cord stimulator, or other active implantable device like a pacemaker, deep brain stimulator, or sacral nerve stimulator
- Have prior experience with spinal cord stimulation
- Be participating in another clinical study
- Have secondary gain issues that could affect study measurements or outcomes
- Be contraindicated for non-invasive cerebral oxygenation measurements (e.g., risk for sensor displacement, non-intact skin on forehead, or ENT surgery)
- Be allergic to adhesives, materials, or fluids used with the CereVu sensor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Boomerang Healthcare
Walnut Creek, California, United States, 94598
Actively Recruiting
Research Team
J
Jon Gasson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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