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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12619001660178
Ethics application status
Approved
Date submitted
25/10/2019
Date registered
27/11/2019
Date last updated
22/10/2021
Date data sharing statement initially provided
27/11/2019
Date results information initially provided
22/10/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Remote Care for patients with implanted deep brain stimulation devices: Feasibility Study
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Scientific title
Remote Care for patients with Parkinson's disease implanted with deep brain stimulation devices: A safety and feasibility Study
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Secondary ID [1]
299626
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ABT-CIP-10311
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Universal Trial Number (UTN)
Nil
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Trial acronym
Nil
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Linked study record
Nil
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Health condition
Health condition(s) or problem(s) studied:
Parkinson’s Disease
314943
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Condition category
Condition code
Neurological
313290
313290
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0
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Parkinson's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Up to thirty-two PD patients will be enrolled in a prospective, double-blind study design in Australia. They will randomly be assigned to remote care paradigm (n = 16) or standard of care protocol (n = 16). For the first session, all subjects will be connected to an experienced programmer remotely via a mobile platform (programmer is off-site) and be in the room (in-clinic) with an expert programmer. The subject will be evaluated first by the in-person clinician and then by the remote clinician while interacting over the mobile platform. During the programming sessions, subjects will be evaluated for PD symptoms and adjustments will be made to their programming parameters accordingly. Both clinicians (neurologist and affiliated nurse practitioner) will be unblinded to the random assignment and the clinician corresponding to the subject’s cohort will save programming parameters on to the subject’s Implantable Pulse Generator (IPG). A third assessor(in-clinic) will determine programming effectiveness acutely (20 mins post session) and over time (3 weeks post first follow-up programming session). Both the subject and the assessor will be blinded to whether the program is saved by the in-person clinician or by the remote clinician. Subjects participating in this clinical investigation will be followed for 3 months (first follow-up programming session, 3-week assessment and 3-month follow-up). Each session is expected to last less than an hour. At each of these sessions, subjects will be assessed for their symptoms and if needed, the clinician will make appropriate adjustments to the programming parameters. The total duration of the clinical investigation is expected to be 9 months.
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Intervention code [1]
315882
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Treatment: Devices
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Intervention code [2]
316047
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Treatment: Other
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Comparator / control treatment
Standard-of-care.
Standard-of-care implies typical clinical practice. In Deep Brain Stimulation (DBS), patients routinely visit their neurologist for adjustments to their programming to manage their PD symptoms. In this scenario, standard-of-care will entail subjects coming in for a programming visit that includes a symptom evaluation and therapy adjustments by the clinician.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary purpose of this investigation is to evaluate the safety of the remote care paradigm. This aim will be achieved by characterizing adverse events (ex: dyskinesias) within the remote care group and standard-of-care group within the 3-week duration post first follow-up programming session. Adverse events will be recorded when all subjects (both groups) return to the clinic for their 3-week assessment. Subjects will also be asked to complete a PD motor diary to log their symptoms.
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Assessment method [1]
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Timepoint [1]
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3 weeks post-randomization.
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Secondary outcome [1]
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The secondary endpoint is the difference in UPDRS-III scores between first follow-up programming and 3-week assessment.
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Assessment method [1]
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Timepoint [1]
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3 weeks post-randomization. UPDRS III will also be assessed at baseline and 3-months.
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Eligibility
Key inclusion criteria
1. Subject must provide written informed consent prior to any clinical investigation related procedure.
2. Subject will be between 21 and 75 years of age
3. Subject is diagnosed with Parkinson’s Disease
4. Subject is implanted in the subthalamic nucleus (STN) with the Abbott Infinity DBS system
5. Subject is willing to maintain a constant dose of anti-Parkinson’s Disease medication indicated as best medical management for at least one month prior to study enrollment
6. Subject has completed at least one programming session
7. Subject is available for appropriate follow-up times for the length of the study
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Minimum age
21
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Subject is currently participating in a clinical investigation that includes an active treatment arm
2. Subject underwent DBS surgery within 90 days prior to screening.
3. Subjects who are pregnant or nursing during the clinical investigation and follow-up period
4. 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 clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
Descriptive statistics will be used to characterize the programming-related adverse event profile of remote care and in-person, standard-of-care DBS programming.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Other reasons/comments
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Other reasons
Impacts of the COVID-19 pandemic.
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Date of first participant enrolment
Anticipated
10/02/2020
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Actual
9/02/2020
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Date of last participant enrolment
Anticipated
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Actual
10/03/2020
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Date of last data collection
Anticipated
30/07/2020
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Actual
22/08/2020
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Sample size
Target
32
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Accrual to date
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Final
11
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
15777
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Brain Surfing Pty Ltd - Spring Hill
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Recruitment postcode(s) [1]
28333
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4000 - Spring Hill
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Abbott
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Address [1]
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6901 Preston Rd.
Plano TX 75024
USA
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Country [1]
304103
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Abbott
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Address
6901 Preston Rd.
Plano TX 75024
USA
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
304318
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Country [1]
304318
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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UnitingCare Health Human Research Ethics Committee
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Ethics committee address [1]
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Ground Floor Moorlands House
The Wesley Hospital
451 Coronation Drive, Auchenflower QLD 4066
PO Box 499 Toowong QLD 4066
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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20/08/2019
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Approval date [1]
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05/11/2019
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Ethics approval number [1]
304591
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Summary
Brief summary
The primary purpose of this investigation is to determine the safety of the remote care paradigm where we evaluate if a clinician can reasonably assess a patient’s Parkinson’s Disease symptoms and adjust their therapy over a mobile platform. We hypothesize that this is safe mode of adjusting therapy.
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Trial website
N/A
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Trial related presentations / publications
N/A
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Public notes
N/A
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Contacts
Principal investigator
Name
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Prof Peter Silburn
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Address
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Brain Surfing Pty Ltd, Level 2, St Andrew’s Place 33 North St Spring Hill QLD 4000
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Country
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Australia
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Phone
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+61 07 3839 3688
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Fax
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+61 07 3839 3588
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Todd Stirman
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Address
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Abbott
6901 Preston Road
Plano, TX 75024 USA
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Country
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United States of America
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Phone
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+19725269625
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Yagna Pathak
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Address
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Abbott
6901 Preston Road
Plano, TX 75024 USA
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Country
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United States of America
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Phone
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+19725264649
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
North American survey on impact of the COVID-19 pandemic shutdown on DBS care
2021
https://doi.org/10.1016/j.parkreldis.2021.10.011
N.B. These documents automatically identified may not have been verified by the study sponsor.
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