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

Sponsored by Abbott Medical Devices

About this study

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.

ADROIT is an international, prospective, multicenter, observational, post-market study intended to collect worldwide long-term safety and effectiveness data on subjects implanted with market-released Abbott DBS systems in routine clinical practice. Subjects will be followed for 5 years after the initial programming visit.

Where this study is enrolling (8)

Show all 8 locations

  • Ohio State Medical

    Columbus, Ohio

    Call 614-366-2420

    This research site can be reached directly by phone. Call to ask about this study.

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  • The Cleveland Clinic Foundation

    Cleveland, Ohio

    Call 216-444-2200

    This research site can be reached directly by phone. Call to ask about this study.

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  • University of Utah Hospital

    Salt Lake City, Utah

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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.