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

N/ACompletedNCT04319887

Saluda Medical Pty Ltd300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Chronic Pain Back Pain Pain

Interventions

Evoke Spinal Cord Stimulation (SCS) SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (22)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System

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.

Time frame: 12-months post-implant

Data from ClinicalTrials.gov

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