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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02924129
Recruitment Status : Completed
First Posted : October 5, 2016
Results First Posted : May 25, 2021
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Saluda Medical Pty Ltd ( Saluda Medical Americas, Inc. )

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.

Condition or disease Intervention/treatment
Chronic Pain Back Pain Pain Device: Evoke Spinal Cord Stimulator (SCS) System

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : January 27, 2017
Actual Primary Completion Date : June 21, 2018
Actual Study Completion Date : September 9, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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).




Primary Outcome Measures :
  1. Number of Participants With Composite Endpoint Success [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in Overall Trunk and Limb VAS Pain Score [ Time Frame: 3 and 12 months ]
    VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.

  2. Change From Baseline in Back VAS Pain Score [ Time Frame: 3 and 12 months ]
    VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.

  3. Change From Baseline in Leg VAS Pain Score [ Time Frame: 3 and 12 months ]
    VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924129


Locations
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United States, California
Thrive Clinic
Santa Rosa, California, United States, 95403
Sponsors and Collaborators
Saluda Medical Americas, Inc.
  Study Documents (Full-Text)

Documents provided by Saluda Medical Pty Ltd ( Saluda Medical Americas, Inc. ):
Study Protocol  [PDF] August 6, 2018
Statistical Analysis Plan  [PDF] February 1, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Saluda Medical Americas, Inc.
ClinicalTrials.gov Identifier: NCT02924129    
Other Study ID Numbers: SCLSH1503
First Posted: October 5, 2016    Key Record Dates
Results First Posted: May 25, 2021
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Saluda Medical Pty Ltd ( Saluda Medical Americas, Inc. ):
Chronic Pain
Back Pain
Leg Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
SCS
Closed Loop
Additional relevant MeSH terms:
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Back Pain
Chronic Pain
Pain
Neurologic Manifestations