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New treatment option for Chronic Pain
Official title Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
ClinicalTrials.gov ID: NCT06559735
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain...
- 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...
- Have prior experience with SCS
- Be concomitantly participating in another clinical study
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Walnut Creek, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Walnut Creek, California, 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.