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Abbott DBS Post-Market Study of Outcomes for Indications Over Time
NCT04071847 · Abbott Medical Devices
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 1000 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2019-11-26
Estimated completion: 2030-09
Last updated: 2026-01-08
Interventions
Device: Deep Brain Stimulation (DBS)
Primary outcomes
- • Change from baseline to 6 months in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. (Baseline to 6 months)
- • Change from baseline to1 year in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. (Baseline to1 year)
- • Change from baseline to 2 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. (Baseline to 2 years)
Sponsor
Abbott Medical Devices · industry
Contacts & investigators
ContactClaudia Salazar, PhD · contact · claudia.salazar4@abbott.com · +1-650-647-3396
ContactShirisha Chiluka · contact · Shirisha.Chiluka@abbott.com · 972-526-4820
InvestigatorDevyani Nanduri · study_director, Abbott Medical Devices Neuromodulation
All locations (48)
University of Aizona Health SciencesActive Not Recruiting
Tucson, Arizona, United States
Cedars-Sinai Medical CenterActive Not Recruiting
Los Angeles, California, United States
University of California at DavisActive Not Recruiting
Sacramento, California, United States
Colorado NeurodiagnosticsTerminated
Littleton, Colorado, United States
Neurosurgery OneWithdrawn
Littleton, Colorado, United States
University of Miami HospitalActive Not Recruiting
Miami, Florida, United States
University of South Florida - Department of NeurologyRecruiting
Tampa, Florida, United States
Rush University Medical CenterRecruiting
Chicago, Illinois, United States
Indiana UniversityRecruiting
Indianapolis, Indiana, United States
Kansas University Medical CenterActive Not Recruiting
Kansas City, Kansas, United States
University of LouisvilleRecruiting
Louisville, Kentucky, United States
Willis-Knighton Medical CenterTerminated
Shreveport, Louisiana, United States
Beth Israe Deaconess Medical CenterActive Not Recruiting
Boston, Massachusetts, United States
Dartmouth Hitchcock Medical CenterActive Not Recruiting
Lebanon, New Hampshire, United States
Albany Medical CenterRecruiting
Albany, New York, United States
The Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Ohio State MedicalRecruiting
Columbus, Ohio, United States
Wright State University & Premier HealthWithdrawn
Fairborn, Ohio, United States
Center for Interventional Pain & SpineWithdrawn
Exton, Pennsylvania, United States
Thomas Jefferson Department or NeurosurgeryActive Not Recruiting
Philadelphia, Pennsylvania, United States
Allegheny General Hospital Department of NeurosurgeryTerminated
Pittsburgh, Pennsylvania, United States
Texas Movement Disorder SpecialistActive Not Recruiting
Georgetown, Texas, United States
University of Utah HospitalRecruiting
Salt Lake City, Utah, United States
Princess Alexandra HospitalRecruiting
Woolloongabba, Queensland, Australia
Royal Melbourne Hospital - City CampusRecruiting
Parkville, Victoria, Australia
Helsinki University Central HospitalRecruiting
Helsinki, Uusimaa, Finland
CHU Gabriel MontpiedWithdrawn
Clermont-Ferrand, Auvergne, France
CHU de St EtienneActive Not Recruiting
Saint-Etienne, Auvergne, France
Fondation RothchildWithdrawn
Paris, ILE, France
CHU Hopital PasteurRecruiting
Nice, Provence-Alpes-Azur, France
Universitäts Klinikum TübingenRecruiting
Tübingen, Baden-Wurttemberg, Germany
Medizinische Einrichtungen der Universität DüsseldorfRecruiting
Düsseldorf, North Rhine-Westphalia, Germany
Universitätsklinikum MünsterRecruiting
Münster, North Rhine-Westphalia, Germany
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität MainzRecruiting
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum des SaarlandesRecruiting
Homburg, Saarland, Germany
UKE Hamburg (Universitatsklinik Eppendorf)Active Not Recruiting
Hamburg, Germany
Az.Osp. Universitaria di FerraraTerminated
Cona, Emilia-Romagna, Italy
Policlinico Universitario A. GemelliRecruiting
Rome, Lazio, Italy
Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaActive Not Recruiting
Milan, Lombardy, Italy
Hospital Virgen de RocioRecruiting
Seville, Andalusia, Spain
Hospital Universitari Germans Trias I PujolRecruiting
Badalona, Catalonia, Spain
Hospital Universitario de la PrincesaRecruiting
Madrid, Spain
Chang Gung Memorial HospitalActive Not Recruiting
Linkou District, Ntaiwan, Taiwan
Hualien Tzu Chi HospitalRecruiting
Hualien City, Taiwan
The Walton CentreActive Not Recruiting
Liverpool, North West England, United Kingdom
Southmead HospitaWithdrawn
Bristol, South West England, United Kingdom
Queen Elizabeth University HospitalRecruiting
Glasgow, Wdbtshr, United Kingdom
King's College HospitalRecruiting
London, United Kingdom