Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation

A Prospective, Observational Study Examining Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Device: CereVu Device

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jon Gasson; Phone Number: 415-233-2119; Email: jgasson@cerevu.com

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Boomerang Healthcare
      • Contact: Kat Abtahi; Phone Number: 925-478-5488; Email: kabtahi@boomeranghc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCS Study Arm; Within subject observational arm measuring non-invasive cerebral oxygenation/flow before, during and after SCS.	Device: CereVu Device; Observational, non-invasive measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional Cerebral Oxygenation/Blood Flow	Opital Spectophotometry measurement from the forehead	1 week
Numerical Pain Rating Scale (NRS)	Subjective pain 11-point pain scale	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress/Anxiety	Hamilton Anxiety Rating Scale	1 week

Collaborators and Investigators

• Sponsor: CereVu Medical, Inc.
• Investigators: Study Director: Jon Gasson, CereVu

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: CIP-5005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No