Spinal Cord Stimulation (SCS) Dosing Study

Last updated: April 6, 2020
Sponsor: MedtronicNeuro
Overall Status: Completed

Phase

4

Condition

Intermittent Claudication

Chronic Pain

Restless Leg Syndrome

Treatment

N/A

Clinical Study ID

NCT03284411
MDT17046
  • Ages > 22
  • All Genders

Study Summary

This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 22 years of age or older

  2. Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month

  3. Has approproate SCS settings

  4. Willing and able to provide signed and dated informed consent

  5. Capable of comprehending and consenting in English

  6. Capable of getting into the supine and sitting positions

  7. Willing and able to comply with all study procedures and visits

  8. On stable (no change in dose, route, or frequency) prescribed pain medications

Exclusion

Exclusion Criteria:

  1. Implanted with leads for peripheral nerve stimulation or an implantable intrathecaldrug delivery system

  2. Had a pain-related surgery in the previous 1 month of enrollment or the intent toundergo surgery during the period of the study

  3. Implanted with quadripolar lead

  4. Currently enrolled or planning to enroll in a potentially confounding clinical studyduring the course of the study

  5. Pregnant or is of child-bearing potential and unwilling to use a medically acceptableform of birth control during the study

  6. Has untreated major psychiatric comorbidity

  7. Has serious drug-related behavioral issues

  8. Has unresolved major issues of secondary gain

Study Design

Total Participants: 30
Study Start date:
November 01, 2017
Estimated Completion Date:
March 15, 2019

Study Description

This feasibility study assessed the following outcomes:

  • Patient satisfaction

  • VAS pain scores

Connect with a study center

  • Arizona Pain Doctors

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Georgia Pain and Wellness Center

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Global Scientific Innovations

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Goodman Campbell Brain and Spine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Kentuckiana Pain Specialists

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Drez One, LLC

    Somerset, Kentucky 42503
    United States

    Site Not Available

  • Regional Brain & Spine

    Cape Girardeau, Missouri 63701
    United States

    Site Not Available

  • Precision Spine Care

    Tyler, Texas 75701
    United States

    Site Not Available

  • Northwest Pain Care, Inc.

    Spokane, Washington 99201
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

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