Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial

Last updated: December 2, 2024
Sponsor: Boston Scientific Corporation
Overall Status: Completed

Phase

N/A

Condition

Chronic Pain

Pain (Pediatric)

Pain

Treatment

Spinal Cord Stimulation

Clinical Study ID

NCT04909593
A4091
  • Ages > 18
  • All Genders

Study Summary

The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Study candidate is undergoing a temporary SCS trial of commercially approved BSCneurostimulator system, per local directions for use (DFU).

  • Subject signed a valid, EC/IRB-approved informed consent form.

  • Age 18 or above, or above legal age and willing and capable of giving informedconsent specific to national law when written informed consent is obtained.

  • In the clinician best judgment, subject is able to distinguishably describe qualityand location of sensation and pain.

Exclusion

Key Exclusion Criteria:

  • Subject meets any contraindication in BSC neurostimulation system local DFU.

  • Investigator-suspected gross lead migration during the SCS trial period which maypreclude the study candidate from receiving adequate SCS therapy.

  • Subject is currently diagnosed with cognitive impairment, or exhibits anycharacteristic, that in the clinician's best judgement would limit study candidate'sability to assess and report sensation information.

  • Subject is currently diagnosed with a physical impairment, or exhibits a conditionthat would limit study candidate's ability to complete study assessments.

Study Design

Total Participants: 21
Treatment Group(s): 1
Primary Treatment: Spinal Cord Stimulation
Phase:
Study Start date:
May 24, 2021
Estimated Completion Date:
November 22, 2022

Connect with a study center

  • PCPMG Clinical Research Unit, LLC

    Greenville, South Carolina 29601
    United States

    Site Not Available

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