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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
5/02/2020
Date data sharing statement initially provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Remote Care for patients with implanted deep brain stimulation devices: Feasibility Study
Scientific title
Remote Care for patients with Parkinson's disease implanted with deep brain stimulation devices: A safety and feasibility Study
Secondary ID [1] 299626 0
ABT-CIP-10311
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Parkinson’s Disease 314943 0
Condition category
Condition code
Neurological 313290 313290 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 6 months (first follow-up programming session, 3-week assessment, 3-month follow-up and 6-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 12 months.
Intervention code [1] 315882 0
Treatment: Devices
Intervention code [2] 316047 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 321773 0
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.
Timepoint [1] 321773 0
3 weeks post-randomization.
Secondary outcome [1] 376167 0
The secondary endpoint is the difference in UPDRS-III scores between first follow-up programming and 3-week assessment.
Timepoint [1] 376167 0
3 weeks post-randomization. UPDRS III will also be assessed at baseline, 3-months and 6-months.

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
Minimum age
21 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15777 0
Brain Surfing Pty Ltd - Spring Hill
Recruitment postcode(s) [1] 28333 0
4000 - Spring Hill

Funding & Sponsors
Funding source category [1] 304103 0
Commercial sector/Industry
Name [1] 304103 0
Abbott
Address [1] 304103 0
6901 Preston Rd.
Plano TX 75024
USA
Country [1] 304103 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Abbott
Address
6901 Preston Rd.
Plano TX 75024
USA
Country
United States of America
Secondary sponsor category [1] 304318 0
None
Name [1] 304318 0
Address [1] 304318 0
Country [1] 304318 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304591 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 304591 0
Ground Floor Moorlands House
The Wesley Hospital
451 Coronation Drive, Auchenflower QLD 4066
PO Box 499 Toowong QLD 4066
Ethics committee country [1] 304591 0
Australia
Date submitted for ethics approval [1] 304591 0
20/08/2019
Approval date [1] 304591 0
05/11/2019
Ethics approval number [1] 304591 0

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.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 97506 0
Prof Peter Silburn
Address 97506 0


Brain Surfing Pty Ltd, Level 2, St Andrew’s Place 33 North St Spring Hill QLD 4000
Country 97506 0
Australia
Phone 97506 0
+61 07 3839 3688
Fax 97506 0
+61 07 3839 3588
Email 97506 0
p.silburn@nsqld.com.au
Contact person for public queries
Name 97507 0
Mr Todd Stirman
Address 97507 0
Abbott
6901 Preston Road
Plano, TX 75024 USA
Country 97507 0
United States of America
Phone 97507 0
+19725269625
Fax 97507 0
Email 97507 0
todd.stirman@abbott.com
Contact person for scientific queries
Name 97508 0
Dr Yagna Pathak
Address 97508 0
Abbott
6901 Preston Road
Plano, TX 75024 USA
Country 97508 0
United States of America
Phone 97508 0
+19725264649
Fax 97508 0
Email 97508 0
yagna.pathak@abbott.com

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 other documents available
Summary results
No Results