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5-Year study tracks brain implant for Parkinson's and tremor

NCT ID NCT04071847

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This international study is following 1,000 people who already have or are getting an Abbott deep brain stimulation (DBS) system to treat Parkinson's disease, essential tremor, or dystonia. Researchers will track how well the device controls symptoms and monitor for serious side effects over five years. The goal is to confirm the long-term safety and effectiveness of DBS for these movement disorders.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Deep brain stimulation (DBS) device
What this could lead to
If successful, this study could confirm that Abbott DBS systems provide lasting symptom control for movement disorders over many years.
What could go wrong
This is an observational post-market study, not a randomized trial, so results may be less definitive. There are also risks from surgery and the device itself, such as infection or lead movement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2019

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will enroll male and female subjects diagnosed with Parkinson's disease, essential tremor or other disabling tremor, or dystonia who are scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Dystonia dystonic disorder essential tremor idiopathic torsion dystonia movement disorder Parkinson disease Tremor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dystonia Essential tremor Movement disorders Parkinson disease Primary dystonia Secondary dystonia Tremor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • Allegheny General Hospital Department of Neurosurgery

    TERMINATED

    Pittsburgh, Pennsylvania, 15212, United States

  • Az.Osp. Universitaria di Ferrara

    TERMINATED

    Cona, Emilia-Romagna, 44124, Italy

  • Beth Israe Deaconess Medical Center

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02215, United States

  • CHU Gabriel Montpied

    WITHDRAWN

    Clermont-Ferrand, Auvergne, 63003, France

  • CHU Hopital Pasteur

    RECRUITING

    Nice, Provence-Alpes-Azur, 6002, France

  • CHU de St Etienne

    ACTIVE_NOT_RECRUITING

    Saint-Etienne, Auvergne, 42270, France

  • Cedars-Sinai Medical Center

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90048, United States

  • Center for Interventional Pain & Spine

    WITHDRAWN

    Exton, Pennsylvania, 19341, United States

  • Chang Gung Memorial Hospital

    ACTIVE_NOT_RECRUITING

    Linkou District, Ntaiwan, 333, Taiwan

  • Colorado Neurodiagnostics

    TERMINATED

    Littleton, Colorado, 80120, United States

  • Dartmouth Hitchcock Medical Center

    ACTIVE_NOT_RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Fondation Rothchild

    WITHDRAWN

    Paris, ILE, France

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

    ACTIVE_NOT_RECRUITING

    Milan, Lombardy, 20133, Italy

  • Helsinki University Central Hospital

    RECRUITING

    Helsinki, Uusimaa, 00290, Finland

  • Hospital Universitari Germans Trias I Pujol

    RECRUITING

    Badalona, Catalonia, 08916, Spain

  • Hospital Universitario de la Princesa

    RECRUITING

    Madrid, 28006, Spain

  • Hospital Virgen de Rocio

    RECRUITING

    Seville, Andalusia, 41013, Spain

  • Hualien Tzu Chi Hospital

    RECRUITING

    Hualien City, 97002, Taiwan

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Kansas University Medical Center

    ACTIVE_NOT_RECRUITING

    Kansas City, Kansas, 66160, United States

  • King's College Hospital

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Medizinische Einrichtungen der Universität Düsseldorf

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Neurosurgery One

    WITHDRAWN

    Littleton, Colorado, 80122, United States

  • Ohio State Medical

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Policlinico Universitario A. Gemelli

    RECRUITING

    Rome, Lazio, 00618, Italy

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Queen Elizabeth University Hospital

    RECRUITING

    Glasgow, Wdbtshr, United Kingdom

  • Royal Melbourne Hospital - City Campus

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Southmead Hospita

    WITHDRAWN

    Bristol, South West England, BS10 5NB, United Kingdom

  • Texas Movement Disorder Specialist

    ACTIVE_NOT_RECRUITING

    Georgetown, Texas, 78628, United States

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • The Walton Centre

    ACTIVE_NOT_RECRUITING

    Liverpool, North West England, L9 7LJ, United Kingdom

  • Thomas Jefferson Department or Neurosurgery

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UKE Hamburg (Universitatsklinik Eppendorf)

    ACTIVE_NOT_RECRUITING

    Hamburg, 20246, Germany

  • UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

    RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

  • University of Aizona Health Sciences

    ACTIVE_NOT_RECRUITING

    Tucson, Arizona, 85274, United States

  • University of California at Davis

    ACTIVE_NOT_RECRUITING

    Sacramento, California, 95817, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Miami Hospital

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33136, United States

  • University of South Florida - Department of Neurology

    RECRUITING

    Tampa, Florida, 33612, United States

  • University of Utah Hospital

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • Universitäts Klinikum Tübingen

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitätsklinikum Münster

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitätsklinikum des Saarlandes

    RECRUITING

    Homburg, Saarland, 66421, Germany

  • Willis-Knighton Medical Center

    TERMINATED

    Shreveport, Louisiana, 71103, United States

  • Wright State University & Premier Health

    WITHDRAWN

    Fairborn, Ohio, 45324, United States

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