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

NCT ID: NCT04071847

Last Updated: 2026-01-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-26

Study Completion Date

2030-09-30

Brief Summary

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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.

Detailed Description

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ADROIT is an international, prospective, multicenter, observational, post-market study intended to collect worldwide long-term safety and effectiveness data on subjects implanted with market-released Abbott DBS systems in routine clinical practice.

Subjects will be followed for 5 years after the initial programming visit.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Deep brain stimulation

Subjects implanted with an Abbott DBS system

Deep Brain Stimulation (DBS)

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status ACTIVE_NOT_RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status ACTIVE_NOT_RECRUITING

University of California at Davis

Sacramento, California, United States

Site Status ACTIVE_NOT_RECRUITING

Colorado Neurodiagnostics

Littleton, Colorado, United States

Site Status TERMINATED

Neurosurgery One

Littleton, Colorado, United States

Site Status WITHDRAWN

University of Miami Hospital

Miami, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

University of South Florida - Department of Neurology

Tampa, Florida, United States

Site Status RECRUITING

Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Indiana University

Indianapolis, Indiana, United States

Site Status RECRUITING

Kansas University Medical Center

Kansas City, Kansas, United States

Site Status ACTIVE_NOT_RECRUITING

University of Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

Willis-Knighton Medical Center

Shreveport, Louisiana, United States

Site Status TERMINATED

Beth Israe Deaconess Medical Center

Boston, Massachusetts, United States

Site Status ACTIVE_NOT_RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status ACTIVE_NOT_RECRUITING

Albany Medical Center

Albany, New York, United States

Site Status RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status RECRUITING

Ohio State Medical

Columbus, Ohio, United States

Site Status RECRUITING

Wright State University & Premier Health

Fairborn, Ohio, United States

Site Status WITHDRAWN

Center for Interventional Pain & Spine

Exton, Pennsylvania, United States

Site Status WITHDRAWN

Thomas Jefferson Department or Neurosurgery

Philadelphia, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Allegheny General Hospital Department of Neurosurgery

Pittsburgh, Pennsylvania, United States

Site Status TERMINATED

Texas Movement Disorder Specialist

Georgetown, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

University of Utah Hospital

Salt Lake City, Utah, United States

Site Status RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status RECRUITING

Royal Melbourne Hospital - City Campus

Parkville, Victoria, Australia

Site Status RECRUITING

Helsinki University Central Hospital

Helsinki, Uusimaa, Finland

Site Status RECRUITING

CHU Gabriel Montpied

Clermont-Ferrand, Auvergne, France

Site Status WITHDRAWN

CHU de St Etienne

Saint-Etienne, Auvergne, France

Site Status ACTIVE_NOT_RECRUITING

Fondation Rothchild

Paris, ILE, France

Site Status WITHDRAWN

CHU Hopital Pasteur

Nice, Provence-Alpes-Azur, France

Site Status RECRUITING

Universitäts Klinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Medizinische Einrichtungen der Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Site Status RECRUITING

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status RECRUITING

Universitätsklinikum des Saarlandes

Homburg, Saarland, Germany

Site Status RECRUITING

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Az.Osp. Universitaria di Ferrara

Cona, Emilia-Romagna, Italy

Site Status TERMINATED

Policlinico Universitario A. Gemelli

Rome, Lazio, Italy

Site Status RECRUITING

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

Milan, Lombardy, Italy

Site Status ACTIVE_NOT_RECRUITING

Hospital Virgen de Rocio

Seville, Andalusia, Spain

Site Status RECRUITING

Hospital Universitari Germans Trias I Pujol

Badalona, Catalonia, Spain

Site Status RECRUITING

Hospital Universitario de la Princesa

Madrid, , Spain

Site Status RECRUITING

Chang Gung Memorial Hospital

Linkou District, Ntaiwan, Taiwan

Site Status ACTIVE_NOT_RECRUITING

Hualien Tzu Chi Hospital

Hualien City, , Taiwan

Site Status RECRUITING

The Walton Centre

Liverpool, North West England, United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Southmead Hospita

Bristol, South West England, United Kingdom

Site Status WITHDRAWN

Queen Elizabeth University Hospital

Glasgow, Wdbtshr, United Kingdom

Site Status RECRUITING

King's College Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Finland France Germany Italy Spain Taiwan United Kingdom

Central Contacts

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Claudia Salazar, PhD

Role: CONTACT

+1-650-647-3396

Shirisha Chiluka

Role: CONTACT

972-526-4820

Facility Contacts

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Konrad Bach

Role: primary

727-798-3789

Neepa Patel

Role: primary

312-563-2900

Kristy Urquhart

Role: backup

Elizabeth Zauber, MD

Role: primary

Andrea Hurt, RC

Role: backup

Anna Williford

Role: primary

502-852-7402

Adam Octavian, MD

Role: primary

518-262-6611

Margaret Czerwinski, RN

Role: backup

518 262 0034

Sean Nagel, MD

Role: primary

216-444-2200

Barbara Changizi, MD

Role: primary

614-366-2420

Julianna Dorsch

Role: primary

801-587-8804

Annette Denny

Role: primary

Anna Nolan

Role: backup

Rebecca Ravenhill

Role: primary

61393428182

Tanja Nojonen

Role: primary

Vanessa Ferrier

Role: primary

00334920375

Siegmar Raidt

Role: primary

Julia Isabell Schiffer, Prof

Role: primary

Sergiu Groppa, Prof.

Role: primary

+4968411624103

Francesco Bove

Role: primary

Rocio Escuela

Role: primary

955923039

Lucia Munoz

Role: primary

0034934978737

Shin-Yuan Chen, MD

Role: primary

0935025340

Catriona Mcneil

Role: primary

Other Identifiers

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ABT-CIP-10300

Identifier Type: -

Identifier Source: org_study_id

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