NCT02924129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 27, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2018

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

May 25, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

September 30, 2016

Results QC Date

March 30, 2021

Last Update Submit

December 14, 2023

Conditions

Chronic PainBack PainPain

Keywords

Chronic PainBack PainLeg PainPainNeurologic ManifestationsNervous System DiseasesSigns and SymptomsSCSClosed Loop

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Percent Change From Baseline in Leg Pain VAS Score

    3 months

  • Percent Change From Baseline in Back Pain VAS Score

    3 months

  • Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score

    3 months

  • Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score

    3 months

  • Number of Participants With Composite Endpoint Success

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Evoke SCS with Feedback

EXPERIMENTAL

closed-loop/automatic stimulation

Device: Evoke Spinal Cord Stimulator (SCS) System

Evoke SCS with Conventional

ACTIVE COMPARATOR

open-loop/manual stimulation

Device: Evoke Spinal Cord Stimulator (SCS) System

Interventions

Evoke Spinal Cord Stimulator (SCS) SystemDEVICE

Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).

Evoke SCS with ConventionalEvoke SCS with Feedback

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Hope Research Institute

Phoenix, Arizona, 85027, United States

Location

Arizona Pain Specialists

Scottsdale, Arizona, 85258, United States

Location

Summit Pain Alliance

Santa Rosa, California, 95401, United States

Location

Thrive Clinic

Santa Rosa, California, 95403, United States

Location

IPM Medical Group

Walnut Creek, California, 94598, United States

Location

Pain Management Associates

Lee's Summit, Missouri, 64086, United States

Location

Premier Pain Centers

Shrewsbury, New Jersey, 07702, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Integrated Pain Solutions

Columbus, Ohio, 43240, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Delaware Valley Pain & Spine Institute

Feasterville-Trevose, Pennsylvania, 19053, United States

Location

Center for Pain Relief

Charleston, West Virginia, 25301, United States

Location

Advanced Pain Management

Greenfield, Wisconsin, 53221, United States

Location

Related Publications (5)

  • Mekhail NA, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Pope JE, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, McJunkin T, Carlson J, Kim CK, Yang MI, Stauss T, Petersen EA, Hagedorn JM, Rauck R, Kallewaard JW, Baranidharan G, Taylor RS, Poree L, Brounstein D, Duarte RV, Gmel GE, Gorman R, Gould I, Hanson E, Karantonis DM, Khurram A, Leitner A, Mugan D, Obradovic M, Ouyang Z, Parker J, Single P, Soliday N; EVOKE Study Group. ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesth Pain Med. 2024 May 7;49(5):346-354. doi: 10.1136/rapm-2023-104751.

    PMID: 37640452DERIVED

  • Kapural L, Mekhail NA, Costandi S, Gilmore C, Pope JE, Li S, Hunter CW, Poree L, Staats PS, Taylor RS, Eldabe S, Kallewaard JW, Thomson S, Petersen EA, Sayed D, Deer TR, Antony A, Budwany R, Leitner A, Soliday N, Duarte RV, Levy RM. Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial. Reg Anesth Pain Med. 2024 Apr 2;49(4):233-240. doi: 10.1136/rapm-2023-104639.

    PMID: 37491149DERIVED

  • Costandi S, Kapural L, Mekhail NA, Jotwani R, Bertisch SM, Li S, Petersen E, Abejon D, Poree L, Ouyang Z, Venkatesan L, Mekhail MN, Gilligan CJ. Impact of Long-Term Evoked Compound Action Potential Controlled Closed-Loop Spinal Cord Stimulation on Sleep Quality in Patients With Chronic Pain: An EVOKE Randomized Controlled Trial Study Subanalysis. Neuromodulation. 2023 Jul;26(5):1030-1038. doi: 10.1016/j.neurom.2022.10.050. Epub 2022 Nov 25.

    PMID: 36437161DERIVED

  • 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.

    PMID: 35088735DERIVED

  • 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.

    PMID: 31870766DERIVED

MeSH Terms

Conditions

Chronic PainBack PainPainNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Interventions

Spinal Cord StimulationDrug Delivery Systems

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationDrug Therapy

Results Point of Contact

Title
Angela Leitner
Organization
Saluda Medical
angela.leitner@saludamedical.com
651-208-4223

Study Officials

  • Dan Brounstein, MBA

    Saluda Medical Americas, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2016

First Posted

October 5, 2016

Study Start

January 27, 2017

Primary Completion

June 21, 2018

Study Completion

September 9, 2022

Last Updated

January 3, 2024

Results First Posted

May 25, 2021

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(16)