Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation

Last updated: August 14, 2024
Sponsor: CereVu Medical, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

CereVu Device

Clinical Study ID

NCT06559735
CIP-5005
  • Ages > 18
  • All Genders

Study 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

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 beenrefractory 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 100mm indicates the worst imaginable pain) at baseline or a 5 on a Numerical RatingScale (NRS)

  4. Be an appropriate candidate for the surgical procedures required in this study basedon 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, andvisits

Exclusion

Exclusion Criteria:

  1. Subject is pregnant or nursing

  2. Have a medical condition or pain in other area(s), not intended to be treated withSCS, that could interfere with study procedures, as determined by the Investigator

  3. Have evidence of an active disruptive psychological or psychiatric disorder or otherknown condition significant enough to impact perception of pain, compliance ofintervention, and/or ability to evaluate treatment outcomes

  4. Have an existing drug pump and/or SCS system or another active implantable devicesuch 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 oroutcomes

  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 onthe forehead, or ENT surgery)

  9. Subject is allergic to any adhesives, materials or fluids in or used in conjunctionwith the CereVu sensor

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: CereVu Device
Phase:
Study Start date:
August 13, 2024
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Boomerang Healthcare

    Walnut Creek, California 94598
    United States

    Active - Recruiting

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