Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation (EVOKE)

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.

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.

Study Overview

• Status: Completed
• Conditions: Pain; Back Pain; Chronic Pain
• Intervention / Treatment: Device: Evoke Spinal Cord Stimulator (SCS) System

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85027
      • Hope Research Institute
    • Scottsdale, Arizona, United States, 85258
      • Arizona Pain Specialists
  • California
    • Santa Rosa, California, United States, 95401
      • Summit Pain Alliance
    • Santa Rosa, California, United States, 95403
      • Thrive Clinic
    • Walnut Creek, California, United States, 94598
      • IPM Medical Group
  • Missouri
    • Lee's Summit, Missouri, United States, 64086
      • Pain Management Associates
  • New Jersey
    • Shrewsbury, New Jersey, United States, 07702
      • Premier Pain Centers
  • New York
    • New York, New York, United States, 10022
      • Ainsworth Institute of Pain Management
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Center for Clinical Research
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43240
      • Integrated Pain Solutions
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Health network
    • Feasterville-Trevose, Pennsylvania, United States, 19053
      • Delaware Valley Pain & Spine Institute
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • Center for Pain Relief
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53221
      • Advanced Pain Management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evoke SCS with Feedback; closed-loop/automatic stimulation	Device: Evoke Spinal Cord Stimulator (SCS) System; Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
Active Comparator: Evoke SCS with Conventional; open-loop/manual stimulation	Device: Evoke Spinal Cord Stimulator (SCS) System; Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Composite Endpoint Success	The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Leg Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.	3 months
Percent Change From Baseline in Back Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.	3 months
Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.	3 months
Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain	3 months
Number of Participants With Composite Endpoint Success	The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.	12 months
Percent Change From Baseline in Leg Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain	12 months
Percent Change From Baseline in Back Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain	12 months
Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain	12 months
Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain	12 months

Collaborators and Investigators

• Sponsor: Saluda Medical Americas, Inc.
• Investigators: Study Director: Dan Brounstein, MBA, Saluda Medical Americas, Inc.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2017
• Primary Completion (Actual): June 21, 2018
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimated): October 5, 2016

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Chronic Pain; Nervous System Diseases; Back Pain; Neurologic Manifestations; Signs and Symptoms; Closed Loop; Leg Pain; SCS
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Chronic Pain
• Other Study ID Numbers: SCLSH1503

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