Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain

Last updated: March 3, 2025
Sponsor: Saluda Medical Pty Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

Evoke Spinal Cord Stimulation (SCS) System

Clinical Study ID

NCT06229470
D103977
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is planning to have a temporary trial with the Evoke System to aid in themanagement of chronic intractable pain of the trunk and/or limbs, includingunilateral or bilateral pain associated with failed back surgery syndrome and/orintractable low back pain and leg pain.

  • Leg pain score ≥ 6 cm (Visual Analog Scale [VAS]).

  • Back pain score ≥ 6 cm (VAS).

  • Subject is able to speak, read, and/or understand English, willing and capable ofgiving informed consent, and able to comply with study-related requirements,procedures, and visits.

  • Subject is not pregnant and not <18 years of age.

Exclusion

Exclusion Criteria:

  • N/A

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Evoke Spinal Cord Stimulation (SCS) System
Phase:
Study Start date:
March 08, 2024
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Lakeside Spine and Pain

    Lake Havasu City, Arizona 86403
    United States

    Active - Recruiting

  • Spanish Hills Interventional Pain Specialists

    Camarillo, California 93010
    United States

    Site Not Available

  • Pain Consultants of San Diego

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Pacific Research Institute

    Santa Rosa, California 94104
    United States

    Active - Recruiting

  • Boomerang Healthcare

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • DBPS Research

    Greenwood Village, Colorado 80111
    United States

    Active - Recruiting

  • Pohlman Pain Associates

    Delray Beach, Florida 33445
    United States

    Active - Recruiting

  • Horizon Clinical Research

    Jasper, Georgia 30143
    United States

    Active - Recruiting

  • Rockford Pain Center

    Rockford, Illinois 61107
    United States

    Active - Recruiting

  • Goodman Campbell Brain and Spine

    Carmel, Indiana 46032
    United States

    Active - Recruiting

  • Metro Anesthesia & Pain Management

    Des Moines, Iowa 50317
    United States

    Active - Recruiting

  • Restorative Pain Institute

    Louisville, Kentucky 40241
    United States

    Active - Recruiting

  • Advanced Pain Institute

    Hammond, Louisiana 70403
    United States

    Active - Recruiting

  • Spine and Joint Institute

    Glen Burnie, Maryland 21061
    United States

    Active - Recruiting

  • Michigan Pain Specialists

    Ann Arbor, Michigan 48108
    United States

    Completed

  • Pain Clinic of Michigan

    Rochester Hills, Michigan 48309
    United States

    Active - Recruiting

  • Tricity Research Center, LLC

    Grand Island, Nebraska 68803
    United States

    Active - Recruiting

  • Reno Tahoe Pain Associates

    Reno, Nevada 89509
    United States

    Active - Recruiting

  • Garden State Pain and Orthopedics

    Clifton, New Jersey 07013
    United States

    Active - Recruiting

  • Seaside Clinical Research Institute

    Wilmington, North Carolina 28412
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Premier Pain Treatment Institute

    Loveland, Ohio 45140
    United States

    Active - Recruiting

  • Carolinas Center for Advanced Management of Pain

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • Institute of Precision Pain Medicine

    Corpus Christi, Texas 78414
    United States

    Active - Recruiting

  • Precision Spine Care

    Tyler, Texas 75701
    United States

    Site Not Available

  • Victoria Pain and Rehabilitation Center

    Victoria, Texas 77904
    United States

    Active - Recruiting

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