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

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

Non Recruiting
18 years and older
All
Phase N/A

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Overview

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

Key Inclusion Criteria:

  • Study candidate is undergoing a temporary SCS trial of commercially approved BSC neurostimulator 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 informed consent specific to national law when written informed consent is obtained.
  • In the clinician best judgment, subject is able to distinguishably describe quality and location of sensation and pain.

Key Exclusion Criteria:

  • Subject meets any contraindication in BSC neurostimulation system local DFU.
  • Investigator-suspected gross lead migration during the SCS trial period which may preclude the study candidate from receiving adequate SCS therapy.
  • Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that in the clinician's best judgement would limit study candidate's ability to assess and report sensation information.
  • Subject is currently diagnosed with a physical impairment, or exhibits a condition that would limit study candidate's ability to complete study assessments.

Study details
    Chronic Pain
    Intractable Pain
    Low Back Pain
    Pain
    Neuropathic
    Pain
    Back

NCT04909593

Boston Scientific Corporation

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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