ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP) (ECAP)

December 9, 2024 updated by: Saluda Medical Pty Ltd

A Prospective, Multicenter, Single-arm Study Examining ECAP-controlled, Closed-loop Stimulation With the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

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 Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Carlsbad, California, United States, 92009
        • Coastal Pain and Spinal Diagnostics
      • Santa Rosa, California, United States, 95403
        • Pacific Research Institute
    • Florida
      • Gainesville, Florida, United States, 32607
        • The Orthopaedic Institute, PA
    • Georgia
      • Atlanta, Georgia, United States, 30326
        • Alliance Spine and Pain Centers
      • Fayetteville, Georgia, United States, 30214
        • Southern Pain and Spine
    • Idaho
      • Hayden Lake, Idaho, United States, 83835
        • Axis Spine Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center Research Institute
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic
    • Minnesota
      • Maple Grove, Minnesota, United States, 55369
        • Interventional Spine and Pain Physicians
    • Nevada
      • Reno, Nevada, United States, 89511
        • Nevada Advanced Pain Specialists
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Tualatin, Oregon, United States, 97062
        • Spinal Diagnostics, PC
    • Pennsylvania
      • Feasterville-Trevose, Pennsylvania, United States, 19053
        • Delaware Valley Pain & Spine Institute
      • Lancaster, Pennsylvania, United States, 55419
        • Center for Interventional Pain and Spine
    • Texas
      • Shenandoah, Texas, United States, 77384
        • Sprintz Center for Pain PLLC
      • Tyler, Texas, United States, 75701
        • Precision Spine Care
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • St. Francis Hospital

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 has chronic intractable pain of the trunk and/or limbs.
  • Subject is willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria:

  • Subject is unable to operate the system.
  • Subject is an unsuitable surgical candidate.
  • Subject has a condition currently requiring or likely to require the use of diathermy.
  • Subject has another implantable stimulator such as demand type pacemakers or cardioverter defibrillator.
  • Subject is <18 years old.
  • Subject is pregnant or nursing.
  • Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body.
  • Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS).

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 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
Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System
Time Frame: 12-months post-implant
Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activation elicited by stimulation with respect to threshold levels. For example, if the dose is at ECAP threshold, this value will be 1. If the dose is 30% higher than ECAP threshold, this value will be 1.3.
12-months post-implant

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Visual Analogue Scale (VAS) to rate pain intensity
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Change in PROMIS-29
Time Frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
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.
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Change in PROMIS-10 Global
Time Frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
10-item instrument that assesses Physical Health and Mental Health
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Change in Profile of Mood States (POMS 2-A Short)
Time Frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
35-item instrument that assesses mood states overall (Total Mood Disturbance) and six mood clusters: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. A scale score is also calculated for Friendliness.
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Rate of Patient Global Impression of Change (PGIC)
Time Frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Single item measure of global improvement with treatment
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Rate of Patient Satisfaction With Therapy
Time Frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Single item measure of satisfaction with treatment
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-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)

October 29, 2020

Primary Completion (Actual)

December 28, 2023

Study Completion (Actual)

December 28, 2023

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-PCL-006732

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

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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