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

Not Applicable

Completed

Conditions: Chronic Pain
Back Pain
Pain

Registration Number: NCT04319887

Lead Sponsor: Saluda Medical Pty Ltd

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 300

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (22): University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Coastal Pain and Spinal Diagnostics
🇺🇸
Carlsbad, California, United States
Pacific Research Institute
🇺🇸
Santa Rosa, California, United States
The Orthopaedic Institute, PA
🇺🇸
Gainesville, Florida, United States
Alliance Spine and Pain Centers
🇺🇸
Atlanta, Georgia, United States
Southern Pain and Spine
🇺🇸
Fayetteville, Georgia, United States
Axis Spine Center
🇺🇸
Hayden Lake, Idaho, United States
University of Kansas Medical Center Research Institute
🇺🇸
Kansas City, Kansas, United States
Ochsner Clinic
🇺🇸
New Orleans, Louisiana, United States
Interventional Spine and Pain Physicians
🇺🇸
Maple Grove, Minnesota, United States
Nevada Advanced Pain Specialists
🇺🇸
Reno, Nevada, United States
Albany Medical College
🇺🇸
Albany, New York, United States
Duke University
🇺🇸
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
Spinal Diagnostics, PC
🇺🇸
Tualatin, Oregon, United States
Delaware Valley Pain & Spine Institute
🇺🇸
Feasterville-Trevose, Pennsylvania, United States
Center for Interventional Pain and Spine
🇺🇸
Lancaster, Pennsylvania, United States
Sprintz Center for Pain PLLC
🇺🇸
Shenandoah, Texas, United States
Precision Spine Care
🇺🇸
Tyler, Texas, United States
St. Francis Hospital
🇺🇸
Charleston, West Virginia, United States