Clinical trial NCT04071847: Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Official title: Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Movement Disorders
Parkinson Disease
Essential Tremor
Tremor
Dystonia
Primary Dystonia
Secondary Dystonia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: Change from baseline to 6 months in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
timeFrame: Baseline to 6 months
measure: Change from baseline to1 year in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
timeFrame: Baseline to1 year
measure: Change from baseline to 2 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
timeFrame: Baseline to 2 years
measure: Change from baseline to 3 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
timeFrame: Baseline to 3 years
measure: Change from baseline to 4 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
timeFrame: Baseline to 4 years
measure: Change from baseline to 5 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
timeFrame: Baseline to 5 years
measure: Change from baseline to 6 months in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
timeFrame: Baseline to 6 months
measure: Change from baseline to 1 year in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
timeFrame: Baseline to 1 year
measure: Change from baseline to 2 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
timeFrame: Baseline to 2 years
measure: Change from baseline to 3 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
timeFrame: Baseline to 3 years
measure: Change from baseline to 4 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
timeFrame: Baseline to 4 years
measure: Change from baseline to 5 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
timeFrame: Baseline to 5 years
measure: Change from baseline to 6 months in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
timeFrame: Baseline to 6 months
measure: Change from baseline to 1 year in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
timeFrame: Baseline to 1 year
measure: Change from baseline to 2 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
timeFrame: Baseline to 2 years
measure: Change from baseline to 3 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
timeFrame: Baseline to 3 years
measure: Change from baseline to 4 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
timeFrame: Baseline to 4 years
measure: Change from baseline to 5 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
timeFrame: Baseline to 5 years
measure: Change from baseline to 6 months in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
timeFrame: Baseline to 6 months
measure: Change from baseline to 1 year in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
timeFrame: Baseline to 1 year
measure: Change from baseline to 2 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
timeFrame: Baseline to 2 years
measure: Change from baseline to 3 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
timeFrame: Baseline to 3 years
measure: Change from baseline to 4 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
timeFrame: Baseline to 4 years
measure: Change from baseline to 5 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
timeFrame: Baseline to 5 years
measure: Incidence of device- and procedure-related serious adverse events at 6 months
timeFrame: At 6 months
measure: Incidence of device- and procedure-related serious adverse events at 1 year
timeFrame: At 1 year
measure: Incidence of device- and procedure-related serious adverse events at 2 years
timeFrame: At 2 years
measure: Incidence of device- and procedure-related serious adverse events at 3 years
timeFrame: At 3 years
measure: Incidence of device- and procedure-related serious adverse events at 4 years
timeFrame: At 4 years
measure: Incidence of device- and procedure-related serious adverse events at 5 years
timeFrame: At 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Aizona Health Sciences
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: University of California at Davis
state: California
city: Littleton
country: United States
facility: Colorado Neurodiagnostics
state: Colorado
city: Littleton
country: United States
facility: Neurosurgery One
state: Colorado
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida - Department of Neurology
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Shreveport
country: United States
facility: Willis-Knighton Medical Center
state: Louisiana
city: Boston
country: United States
facility: Beth Israe Deaconess Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State Medical
state: Ohio
city: Fairborn
country: United States
facility: Wright State University & Premier Health
state: Ohio
city: Exton
country: United States
facility: Center for Interventional Pain & Spine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson Department or Neurosurgery
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital Department of Neurosurgery
state: Pennsylvania
city: Georgetown
country: United States
facility: Texas Movement Disorder Specialist
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Parkville
country: Australia
facility: Royal Melbourne Hospital - City Campus
state: Victoria
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: Uusimaa
city: Clermont Ferrand
country: France
facility: CHU Gabriel Montpied
state: Auvergne
city: Saint-Étienne
country: France
facility: CHU de St Etienne
state: Auvergne
city: Paris
country: France
facility: Fondation Rothchild
state: ILE
city: Nice
country: France
facility: CHU Hopital Pasteur
state: Provence-Alpes-Azur
city: Tübingen
country: Germany
facility: Universitäts Klinikum Tübingen
state: Baden-Wurttemberg
city: Düsseldorf
country: Germany
facility: Medizinische Einrichtungen der Universität Düsseldorf
state: North Rhine-Westphalia
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: North Rhine-Westphalia
city: Mainz
country: Germany
facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
state: Rhineland-Palatinate
city: Hamburg
country: Germany
facility: UKE Hamburg (Universitatsklinik Eppendorf)
city: Cona
country: Italy
facility: Az.Osp. Universitaria di Ferrara
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli
state: Latium
city: Milano
country: Italy
facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
state: Lombardy
city: Sevilla
country: Spain
facility: Hospital Virgen de Rocio
state: Andalusia
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
state: Catalonia
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: LinKou
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Ntaiwan
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Liverpool
country: United Kingdom
facility: The Walton Centre
state: North West England
city: Bristol
country: United Kingdom
facility: Southmead Hospita
state: South West England
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
state: Wdbtshr
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: Abbott Medical Devices Neuromodulation
name: Devyani Nanduri
role: STUDY_DIRECTOR
References: