RecruitingNCT04071847
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Sponsor
Abbott Medical Devices
Enrollment
1,000 participants
Start Date
Nov 26, 2019
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria4
- 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.
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)
View Full Details on ClinicalTrials.gov
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NCT04071847
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