Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CereVu Device.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Observational Study Examining Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
Overview
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
Interventions
- Device CereVu Device
Observational, non-invasive measurements
Primary outcome measures
- Regional Cerebral Oxygenation/Blood Flow [Time frame: 1 week]
- Numerical Pain Rating Scale (NRS) [Time frame: 1 week]
Secondary outcome measures (1)
- Stress/Anxiety [Time frame: 1 week]
Eligibility criteria
Inclusion 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Boomerang Healthcare — Walnut Creek
Identifiers
NCT: NCT06559735 · CIP-5005