Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation

Not Applicable

Recruiting

• Conditions: Chronic Pain
• Interventions: Device: CereVu Device

• Registration Number: NCT06559735
• Lead Sponsor: CereVu Medical, Inc.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-12
• Study Start: 2024-08-13
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCS Study Arm	CereVu Device	Within subject observational arm measuring non-invasive cerebral oxygenation/flow before, during and after SCS.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Stress/Anxiety	1 week	Hamilton Anxiety Rating Scale

Trial Locations

Locations (1)

Boomerang Healthcare; 🇺🇸 Walnut Creek, California, United States