Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation

NCT06559735 | Recruiting FDA Device

• 1 other identifier: CIP-5005
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Stress/Anxiety

  1 week

Study Arms (1)

SCS Study Arm

EXPERIMENTAL

Within subject observational arm measuring non-invasive cerebral oxygenation/flow before, during and after SCS.

Device: CereVu Device

Interventions

CereVu Device DEVICE

Observational, non-invasive measurements

SCS Study Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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 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

Sponsors & Collaborators

• CereVu Medical, Inc.: lead

Study Sites (1)

Boomerang Healthcare

Walnut Creek, California, 94598, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jon Gasson

  CereVu

  STUDY DIRECTOR

Central Study Contacts

Jon Gasson

CONTACT

415-233-2119; jgasson@cerevu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 19, 2024
• Study Start: August 13, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)