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

  • STATUS
    Recruiting
  • End date
    Sep 12, 2030
  • participants needed
    1000
  • sponsor
    Abbott Medical Devices
Updated on 12 July 2021
Investigator
Edward Karst, PhD
Primary Contact
Willis-Knighton Medical Center (2.2 mi away) Contact
+33 other location
parkinson's disease
deep brain stimulation
brain stimulation
motor symptoms
dystonia
tremor
essential tremor

Summary

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.

Description

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.

Details
Condition Orofacial Dyskinesia, Dystonia, Tremor, Essential Tremor, Dystonia, Parkinson's disease, Dystonias, movement disorder, parkinson's, parkinson disease, shakes, shake, movement disorders, primary dystonia
Treatment Deep Brain Stimulation (DBS)
Clinical Study IdentifierNCT04071847
SponsorAbbott Medical Devices
Last Modified on12 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days
Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure

Exclusion Criteria

Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study
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
Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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