Clinical trial NCT04319887: ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Back Pain
Pain
Keywords: Chronic Pain
Back Pain
Leg Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
SCS
Closed Loop
Lead sponsor: Saluda Medical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2020-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System
timeFrame: 12-months post-implant
Secondary outcomes:
Other outcomes:
measure: Change in Pain
timeFrame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
measure: Change in PROMIS-29
timeFrame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
measure: Change in PROMIS-10 Global
timeFrame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
measure: Change in Profile of Mood States (POMS 2-A Short)
timeFrame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
measure: Rate of Patient Global Impression of Change (PGIC)
timeFrame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
measure: Rate of Patient Satisfaction With Therapy
timeFrame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Carlsbad
country: United States
facility: Coastal Pain and Spinal Diagnostics
state: California
city: Santa Rosa
country: United States
facility: Pacific Research Institute
state: California
city: Gainesville
country: United States
facility: The Orthopaedic Institute, PA
state: Florida
city: Atlanta
country: United States
facility: Alliance Spine and Pain Centers
state: Georgia
city: Fayetteville
country: United States
facility: Southern Pain and Spine
state: Georgia
city: Hayden Lake
country: United States
facility: Axis Spine Center
state: Idaho
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Maple Grove
country: United States
facility: Interventional Spine and Pain Physicians
state: Minnesota
city: Reno
country: United States
facility: Nevada Advanced Pain Specialists
state: Nevada
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Tualatin
country: United States
facility: Spinal Diagnostics, PC
state: Oregon
city: Feasterville-Trevose
country: United States
facility: Delaware Valley Pain & Spine Institute
state: Pennsylvania
city: Lancaster
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
city: Shenandoah
country: United States
facility: Sprintz Center for Pain PLLC
state: Texas
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Charleston
country: United States
facility: St. Francis Hospital
state: West Virginia
Study officials:
References: