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

Recruiting now

Conditions studied: Movement Disorders, Parkinson Disease, Essential Tremor, Tremor, Dystonia, Primary Dystonia, Secondary Dystonia

In brief

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.

Key facts

Study ID

NCT04071847

Run by

Abbott Medical Devices

People needed

1000

Starts

2019-11-26

Expected to finish

2030-09-01

Last updated by the study team

2026-01-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• King's College Hospital — London, United Kingdom (enrolling)
• University of South Florida - Department of Neurology — Tampa, Florida, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• Albany Medical Center — Albany, New York, United States (enrolling)
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Ohio State Medical — Columbus, Ohio, United States (enrolling)
• University of Utah Hospital — Salt Lake City, Utah, United States (enrolling)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
• Royal Melbourne Hospital - City Campus — Parkville, Victoria, Australia (enrolling)
• Helsinki University Central Hospital — Helsinki, Uusimaa, Finland (enrolling)
• CHU Hopital Pasteur — Nice, Provence-Alpes-Azur, France (enrolling)
• Universitäts Klinikum Tübingen — Tübingen, Baden-Wurttemberg, Germany (enrolling)
• Medizinische Einrichtungen der Universität Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany (enrolling)
• Universitätsklinikum Münster — Münster, North Rhine-Westphalia, Germany (enrolling)
• UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz — Mainz, Rhineland-Palatinate, Germany (enrolling)
• Universitätsklinikum des Saarlandes — Homburg, Saarland, Germany (enrolling)
• Policlinico Universitario A. Gemelli — Rome, Lazio, Italy (enrolling)
• Hospital Virgen de Rocio — Seville, Andalusia, Spain (enrolling)
• Hospital Universitari Germans Trias I Pujol — Badalona, Catalonia, Spain (enrolling)
• Hospital Universitario de la Princesa — Madrid, Spain (enrolling)
• Hualien Tzu Chi Hospital — Hualien City, Taiwan (enrolling)
• Queen Elizabeth University Hospital — Glasgow, Wdbtshr, United Kingdom (enrolling)
• Southmead Hospita — Bristol, South West England, United Kingdom

Full record on ClinicalTrials.gov

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