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

Movement Disorders Parkinson Disease Dystonia Tremor Essential Tremor Primary Dystonia Secondary Dystonia

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

Plain Language Summary

Simplified for easier understanding

This is a post-market observational study tracking long-term outcomes in patients who receive deep brain stimulation (DBS) devices made by Abbott. Researchers want to understand how DBS performs across different conditions over time in real-world settings. **You may be eligible if...** - You are scheduled to receive a new Abbott DBS implant or have your existing device's battery replaced within the next 180 days - You or your legal representative can provide written informed consent **You may NOT be eligible if...** - You are enrolled in another investigational study that might affect the results - You have medical, social, or psychological conditions that would prevent you from following study requirements or that might affect the scientific reliability of the data - The study center is located in the United States and your condition is not approved for DBS in the US Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Sciences

Tucson, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California at Davis

Sacramento, California, United States

Colorado Neurodiagnostics

Littleton, Colorado, United States

Neurosurgery One

Littleton, Colorado, United States

University of Miami Hospital

Miami, Florida, United States

University of South Florida - Department of Neurology

Tampa, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Kansas University Medical Center

Kansas City, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

Willis-Knighton Medical Center

Shreveport, Louisiana, United States

Beth Israe Deaconess Medical Center

Boston, Massachusetts, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Albany Medical Center

Albany, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State Medical

Columbus, Ohio, United States

Wright State University & Premier Health

Fairborn, Ohio, United States

Center for Interventional Pain & Spine

Exton, Pennsylvania, United States

Thomas Jefferson Department or Neurosurgery

Philadelphia, Pennsylvania, United States

Allegheny General Hospital Department of Neurosurgery

Pittsburgh, Pennsylvania, United States

Texas Movement Disorder Specialist

Georgetown, Texas, United States

University of Utah Hospital

Salt Lake City, Utah, United States

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Melbourne Hospital - City Campus

Parkville, Victoria, Australia

Helsinki University Central Hospital

Helsinki, Uusimaa, Finland

CHU Gabriel Montpied

Clermont-Ferrand, Auvergne, France

CHU de St Etienne

Saint-Etienne, Auvergne, France

Fondation Rothchild

Paris, ILE, France

CHU Hopital Pasteur

Nice, Provence-Alpes-Azur, France

Universitäts Klinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Medizinische Einrichtungen der Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, Germany

Universitätsklinikum des Saarlandes

Homburg, Saarland, Germany

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, Germany

Az.Osp. Universitaria di Ferrara

Cona, Emilia-Romagna, Italy

Policlinico Universitario A. Gemelli

Rome, Lazio, Italy

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy

Hospital Virgen de Rocio

Seville, Andalusia, Spain

Hospital Universitari Germans Trias I Pujol

Badalona, Catalonia, Spain

Hospital Universitario de la Princesa

Madrid, Spain

Chang Gung Memorial Hospital

Linkou District, Ntaiwan, Taiwan

Hualien Tzu Chi Hospital

Hualien City, Taiwan

The Walton Centre

Liverpool, North West England, United Kingdom

Southmead Hospita

Bristol, South West England, United Kingdom

Queen Elizabeth University Hospital

Glasgow, Wdbtshr, United Kingdom

King's College Hospital

London, United Kingdom

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NCT04071847

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(48)

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