Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain (Neural Panel)

April 19, 2024 updated by: Saluda Medical Pty Ltd

A Prospective, Multicenter, Single-arm Study Evaluating the Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop Spinal Cord Stimulation (SCS) to Guide Treatment of Patients With Chronic Pain of the Trunk and/or Limbs.

The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

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
    • Arizona
      • Lake Havasu City, Arizona, United States, 86403
        • Recruiting
        • Lakeside Spine and Pain
    • California
      • Camarillo, California, United States, 93010
        • Recruiting
        • Spanish Hills Interventional Pain Specialists
      • La Mesa, California, United States, 91942
        • Recruiting
        • Pain Consultants of San Diego
      • Santa Rosa, California, United States, 94104
        • Recruiting
        • Pacific Research Institute
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Boomerang Healthcare
    • Florida
      • Delray Beach, Florida, United States, 33445
        • Recruiting
        • Pohlman Pain Associates
    • Georgia
      • Jasper, Georgia, United States, 30143
        • Recruiting
        • Horizon Clinical Research
    • Illinois
      • Rockford, Illinois, United States, 61107
        • Recruiting
        • Rockford Pain Center
    • Iowa
      • Des Moines, Iowa, United States, 50317
        • Recruiting
        • Metro Anesthesia & Pain Management
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Recruiting
        • Restorative Pain Institute
    • Louisiana
      • Hammond, Louisiana, United States, 70403
        • Recruiting
        • Advanced Pain Institute
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • Spine and Joint Institute
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Recruiting
        • Tricity Research Center, LLC
    • Nevada
      • Reno, Nevada, United States, 89509
        • Recruiting
        • Reno Tahoe Pain Associates
    • New Jersey
      • Clifton, New Jersey, United States, 07013
        • Recruiting
        • Garden State Pain and Orthopedics
    • North Carolina
      • Wilmington, North Carolina, United States, 28412
        • Recruiting
        • Seaside Clinical Research Institute
    • Ohio
      • Loveland, Ohio, United States, 45140
        • Recruiting
        • Premier Pain Treatment Institute
    • Texas
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Precision Spine Care
      • Victoria, Texas, United States, 77904
        • Recruiting
        • Victoria Pain and Rehabilitation Center

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:

  • Subject is planning to have a temporary trial with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain.
  • Leg pain score ≥ 6 cm (Visual Analog Scale [VAS]).
  • Back pain score ≥ 6 cm (VAS).
  • Subject is able to speak, read, and/or understand English, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits.
  • Subject is not pregnant and not <18 years of age.

Exclusion Criteria:

  • N/A

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECAP-Controlled, Closed-Loop SCS
Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.
Device: Evoke Spinal Cord Stimulation (SCS) System
A spinal cord stimulation (SCS) system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
Time Frame: through 6-months post-implant
physiological parameter to be measured = Evoked Compound Action Potentials (ECAPs); measurement tool = Evoke SCS System
through 6-months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analogue Scale (VAS) Pain
Time Frame: through 6-months post-implant
Visual Analogue Scale (VAS) to rate pain intensity (0mm [no pain] to 100mm [worst pain imaginable])
through 6-months post-implant
Change in PROMIS-29+2
Time Frame: through 6-months post-implant
PROMIS-29 Profile and 2 PROMIS Cognitive Function Abilities items. The PROMIS-29 is a 29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity.
through 6-months post-implant
Change in PROMIS-10 Global Health
Time Frame: through 6-months post-implant
10-item instrument that assesses Physical Health and Mental Health
through 6-months post-implant

Collaborators and Investigators

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

Sponsor

Saluda Medical Pty Ltd

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)

March 8, 2024

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D103977

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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