Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation

August 14, 2024 updated by: CereVu Medical, Inc.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Walnut Creek, California, United States, 94598

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 week
Opital Spectophotometry measurement from the forehead
1 week
Numerical Pain Rating Scale (NRS)
Time Frame: 1 week
Subjective pain 11-point pain scale
1 week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CereVu Medical, Inc.

Investigators

  • Study Director: Jon Gasson, CereVu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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