Local Cerebral Oxygenation in Chronic Pain Patients Utili... | NCT06559735

Studies
Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation

NCT06559735

Sponsor

CereVu Medical, Inc.

Status

Recruiting

Last Update Posted

Aug 19, 2024Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Chronic Pain

Interventions

CereVu Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 13, 2024Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Aug 12, 2024

First Submission Date that Met QC Criteria

Aug 14, 2024

First Posted Date

Aug 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2024

Last Update Posted Date

Aug 19, 2024Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CereVu Device	Device	Observational, non-invasive measurements	SCS Study Arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms