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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04071847




Registration number
NCT04071847
Ethics application status
Date submitted
26/08/2019
Date registered
28/08/2019

Titles & IDs
Public title
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Scientific title
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Secondary ID [1] 0 0
ABT-CIP-10300
Universal Trial Number (UTN)
Trial acronym
ADROIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Movement Disorders 0 0
Parkinson Disease 0 0
Essential Tremor 0 0
Tremor 0 0
Dystonia 0 0
Primary Dystonia 0 0
Secondary Dystonia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Deep Brain Stimulation (DBS)

Deep brain stimulation - Subjects implanted with an Abbott DBS system


Treatment: Devices: 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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to 6 months in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
Timepoint [1] 0 0
Baseline to 6 months
Primary outcome [2] 0 0
Change from baseline to1 year in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
Timepoint [2] 0 0
Baseline to1 year
Primary outcome [3] 0 0
Change from baseline to 2 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
Timepoint [3] 0 0
Baseline to 2 years
Primary outcome [4] 0 0
Change from baseline to 3 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
Timepoint [4] 0 0
Baseline to 3 years
Primary outcome [5] 0 0
Change from baseline to 4 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
Timepoint [5] 0 0
Baseline to 4 years
Primary outcome [6] 0 0
Change from baseline to 5 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
Timepoint [6] 0 0
Baseline to 5 years
Primary outcome [7] 0 0
Change from baseline to 6 months in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
Timepoint [7] 0 0
Baseline to 6 months
Primary outcome [8] 0 0
Change from baseline to 1 year in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
Timepoint [8] 0 0
Baseline to 1 year
Primary outcome [9] 0 0
Change from baseline to 2 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
Timepoint [9] 0 0
Baseline to 2 years
Primary outcome [10] 0 0
Change from baseline to 3 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
Timepoint [10] 0 0
Baseline to 3 years
Primary outcome [11] 0 0
Change from baseline to 4 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
Timepoint [11] 0 0
Baseline to 4 years
Primary outcome [12] 0 0
Change from baseline to 5 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
Timepoint [12] 0 0
Baseline to 5 years
Primary outcome [13] 0 0
Change from baseline to 6 months in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
Timepoint [13] 0 0
Baseline to 6 months
Primary outcome [14] 0 0
Change from baseline to 1 year in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
Timepoint [14] 0 0
Baseline to 1 year
Primary outcome [15] 0 0
Change from baseline to 2 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
Timepoint [15] 0 0
Baseline to 2 years
Primary outcome [16] 0 0
Change from baseline to 3 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
Timepoint [16] 0 0
Baseline to 3 years
Primary outcome [17] 0 0
Change from baseline to 4 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
Timepoint [17] 0 0
Baseline to 4 years
Primary outcome [18] 0 0
Change from baseline to 5 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
Timepoint [18] 0 0
Baseline to 5 years
Primary outcome [19] 0 0
Change from baseline to 6 months in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
Timepoint [19] 0 0
Baseline to 6 months
Primary outcome [20] 0 0
Change from baseline to 1 year in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
Timepoint [20] 0 0
Baseline to 1 year
Primary outcome [21] 0 0
Change from baseline to 2 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
Timepoint [21] 0 0
Baseline to 2 years
Primary outcome [22] 0 0
Change from baseline to 3 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
Timepoint [22] 0 0
Baseline to 3 years
Primary outcome [23] 0 0
Change from baseline to 4 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
Timepoint [23] 0 0
Baseline to 4 years
Primary outcome [24] 0 0
Change from baseline to 5 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
Timepoint [24] 0 0
Baseline to 5 years
Primary outcome [25] 0 0
Incidence of device- and procedure-related serious adverse events at 6 months
Timepoint [25] 0 0
At 6 months
Primary outcome [26] 0 0
Incidence of device- and procedure-related serious adverse events at 1 year
Timepoint [26] 0 0
At 1 year
Primary outcome [27] 0 0
Incidence of device- and procedure-related serious adverse events at 2 years
Timepoint [27] 0 0
At 2 years
Primary outcome [28] 0 0
Incidence of device- and procedure-related serious adverse events at 3 years
Timepoint [28] 0 0
At 3 years
Primary outcome [29] 0 0
Incidence of device- and procedure-related serious adverse events at 4 years
Timepoint [29] 0 0
At 4 years
Primary outcome [30] 0 0
Incidence of device- and procedure-related serious adverse events at 5 years
Timepoint [30] 0 0
At 5 years

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2030
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - City Campus - Parkville
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
Finland
State/province [17] 0 0
Uusimaa
Country [18] 0 0
France
State/province [18] 0 0
Auvergne
Country [19] 0 0
France
State/province [19] 0 0
ILE
Country [20] 0 0
France
State/province [20] 0 0
Provence-Alpes-Azur
Country [21] 0 0
Germany
State/province [21] 0 0
Baden-Wurttemberg
Country [22] 0 0
Germany
State/province [22] 0 0
North Rhine-Westphalia
Country [23] 0 0
Germany
State/province [23] 0 0
Rhineland-Palatinate
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Italy
State/province [25] 0 0
Emilia-Romagna
Country [26] 0 0
Italy
State/province [26] 0 0
Latium
Country [27] 0 0
Italy
State/province [27] 0 0
Lombardy
Country [28] 0 0
Spain
State/province [28] 0 0
Andalusia
Country [29] 0 0
Spain
State/province [29] 0 0
Catalonia
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Taiwan
State/province [31] 0 0
Ntaiwan
Country [32] 0 0
Taiwan
State/province [32] 0 0
Hualien City
Country [33] 0 0
United Kingdom
State/province [33] 0 0
North West England
Country [34] 0 0
United Kingdom
State/province [34] 0 0
South West England
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Wdbtshr
Country [36] 0 0
United Kingdom
State/province [36] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Devyani Nanduri
Address 0 0
Abbott Medical Devices Neuromodulation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Natalie Brill, PhD
Address 0 0
Country 0 0
Phone 0 0
+15122864383
Fax 0 0
Email 0 0
Natalie.Brill@abbott.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04071847