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

RecruitingObservational study

Who can join

All ages · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Abbott Medical Devices · Participants: 1,000 · Started: Nov 26, 2019

Contact the study team

Official record on ClinicalTrials.gov — NCT04071847

Locations in the U.S.

FloridaUniversity of South Florida - Department of Neurology, Tampa
IllinoisRush University Medical Center, Chicago
IndianaIndiana University, Indianapolis
KentuckyUniversity of Louisville, Louisville
New YorkAlbany Medical Center, Albany
OhioThe Cleveland Clinic Foundation, Cleveland
Ohio State Medical, Columbus
UtahUniversity of Utah Hospital, Salt Lake City

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.