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Abbott DBS Post-Market Study of Outcomes for Indications Over Time

Recruitingn/aAges any - anyAllAbbott Medical Devices
NCT04071847 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days. 2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure. Exclusion Criteria: 1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study. 2. Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results. 3. Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor. 4. Study center is located in the United States, and the intended lead implant location is not at, or in close proximity to, the STN, GPi, or VIM thalamus.
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What it tests

  • Deep Brain Stimulation (DBS)
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Where

48 sites
University of Aizona Health Sciences
Tucson, United States
Cedars-Sinai Medical Center
Los Angeles, United States
University of California at Davis
Sacramento, United States
Colorado Neurodiagnostics
Littleton, United States
Neurosurgery One
Littleton, United States
University of Miami Hospital
Miami, United States
University of South Florida - Department of Neurology
Tampa, United States
Rush University Medical Center
Chicago, United States

…and 40 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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