Clinical trial NCT02924129: Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation
Official title: A Prospective, Multicenter, Randomized Double-blind Study Examining the Safety and Efficacy of Using the Evoke™ Spinal Cord Stimulator (SCS) System With Feedback 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: 2016-10-05
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.


Eligibility criteria: Inclusion Criteria:

* Subject is male or female between the ages of 18 and 80 years.
* Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
* Be an appropriate candidate for an SCS trial and the surgical procedures required in this study based on the clinical judgment of the Investigator.
* Be willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria:

* Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator.
* Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
* Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).
* Have prior experience with SCS.
* Have an active systemic infection or local infection in the area of the surgical site.
* Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal).
* Be concomitantly participating in another clinical study.

Primary outcomes:
measure: Number of Participants With Composite Endpoint Success
timeFrame: 3 months
Secondary outcomes:
measure: Percent Change From Baseline in Leg Pain VAS Score
timeFrame: 3 months
measure: Percent Change From Baseline in Back Pain VAS Score
timeFrame: 3 months
measure: Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score
timeFrame: 3 months
measure: Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score
timeFrame: 3 months
measure: Number of Participants With Composite Endpoint Success
timeFrame: 12 months
measure: Percent Change From Baseline in Leg Pain VAS Score
timeFrame: 12 months
measure: Percent Change From Baseline in Back Pain VAS Score
timeFrame: 12 months
measure: Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score
timeFrame: 12 months
measure: Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Pain Specialists
state: Arizona
city: Santa Rosa
country: United States
facility: Summit Pain Alliance
state: California
city: Santa Rosa
country: United States
facility: Thrive Clinic
state: California
city: Walnut Creek
country: United States
facility: IPM Medical Group
state: California
city: Lee's Summit
country: United States
facility: Pain Management Associates
state: Missouri
city: Shrewsbury
country: United States
facility: Premier Pain Centers
state: New Jersey
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Winston-Salem
country: United States
facility: Center for Clinical Research
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: Columbus
country: United States
facility: Integrated Pain Solutions
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Feasterville-Trevose
country: United States
facility: Delaware Valley Pain & Spine Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Center for Pain Relief
state: West Virginia
city: Greenfield
country: United States
facility: Advanced Pain Management
state: Wisconsin
Study officials:
affiliation: Saluda Medical Americas, Inc.
name: Dan Brounstein, MBA
role: STUDY_DIRECTOR
References:
citation: Falowski SM, Kim CH, Obradovic M, Parker JL. A Prospective Multicenter Case Series Utilizing Intraoperative Neuromonitoring With Evoked Compound Action Potentials to Confirm Spinal Cord Stimulation Lead Placement. Neuromodulation. 2022 Jul;25(5):724-730. doi: 10.1016/j.neurom.2021.11.014. Epub 2022 Jan 26.
citation: Mekhail N, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Pope JE, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, Carlson J, Kim CK, Yang MI, Stauss T, Poree L; Evoke Study Group. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. 2020 Feb;19(2):123-134. doi: 10.1016/S1474-4422(19)30414-4. Epub 2019 Dec 20.