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Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

Recruiting
18 years and older
All
Phase N/A

Overview

The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.

Eligibility

Key Inclusion Criteria:

  • Implanted bilaterally in STN or GPi with a Vercise™ DBS system for Parkinson's disease, including directional leads, for at least four months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks.
  • Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
  • Be at least 18 years of age.
  • Device must have been implanted on label or must be on label by the time the subject gets enrolled.

Key Exclusion Criteria:

  • Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.

Study details
    Parkinson Disease

NCT03037398

Boston Scientific Corporation

13 December 2024

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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.

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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.

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