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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAbbott Medical Devices

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Deep Brain Stimulation (DBS)

Treatment groups

1,000 Participants
are divided into 1 treatment group

Sponsors and collaborators