Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Abbott Medical Devices
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.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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 abili…
Interventions
- DeviceDeep Brain Stimulation (DBS)
Deep brain stimulation therapy involves the delivery of electrical signals to targeted structures in the brain to modulate neural circuit activity, and has been used successfully for the treatment of various types of movement disorders, including Parkinson's disease (PD), disabling or essential tremor, and dystonia
Locations (48)
- University of Aizona Health SciencesTucson, Arizona
- Cedars-Sinai Medical CenterLos Angeles, California
- University of California at DavisSacramento, California
- Colorado NeurodiagnosticsLittleton, Colorado
- Neurosurgery OneLittleton, Colorado
- University of Miami HospitalMiami, Florida