Abbott DBS Post-Market Study of Outcomes for Indications Over Time
NCT ID: NCT04071847
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2019-11-26
2030-09-30
Brief Summary
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Detailed Description
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Subjects will be followed for 5 years after the initial programming visit.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Deep brain stimulation
Subjects implanted with an Abbott DBS system
Deep 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
Interventions
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Deep 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
Eligibility Criteria
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Inclusion Criteria
2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.
Exclusion Criteria
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.
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Devyani Nanduri
Role: STUDY_DIRECTOR
Abbott Medical Devices Neuromodulation
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Sean Nagel, MD
Role: primary
Barbara Changizi, MD
Role: primary
Julia Isabell Schiffer, Prof
Role: primary
Other Identifiers
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ABT-CIP-10300
Identifier Type: -
Identifier Source: org_study_id
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