Clinical trial NCT06559735: Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
Official title: A Prospective, Observational Study Examining Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: CereVu Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 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


Eligibility 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

Primary outcomes:
measure: Regional Cerebral Oxygenation/Blood Flow
timeFrame: 1 week
measure: Numerical Pain Rating Scale (NRS)
timeFrame: 1 week
Secondary outcomes:
measure: Stress/Anxiety
timeFrame: 1 week
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Boomerang Healthcare
state: California
Study officials:
affiliation: CereVu
name: Jon Gasson
role: STUDY_DIRECTOR
References: