Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation

NCT ID: NCT06559735

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-13
• Study Completion Date: 2025-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

SCS Study Arm

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

Group Type: EXPERIMENTAL

CereVu Device

Intervention Type: DEVICE

Observational, non-invasive measurements

Interventions

CereVu Device

Observational, non-invasive measurements

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CereVu Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Gasson

Role: STUDY_DIRECTOR

CereVu

Locations

Boomerang Healthcare

Walnut Creek, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jon Gasson

Role: CONTACT

jgasson@cerevu.com

415-233-2119

Facility Contacts

Kat Abtahi

Role: primary

kabtahi@boomeranghc.com

925-478-5488

Other Identifiers

CIP-5005

Identifier Type: -

Identifier Source: org_study_id