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