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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02989610
Registration number
NCT02989610
Ethics application status
Date submitted
8/12/2016
Date registered
12/12/2016
Date last updated
14/07/2022
Titles & IDs
Public title
Clinical Evaluation of the Infinity Deep Brain Stimulation System
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Scientific title
Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System
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Secondary ID [1]
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SJM-CIP-10061
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Universal Trial Number (UTN)
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Trial acronym
PROGRESS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Parkinson Disease
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Condition category
Condition code
Neurological
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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
Treatment: Devices - Omnidirectional stimulation
Treatment: Devices - Directional stimulation
Experimental: Omnidirectional followed by directional DBS - Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for months 3-6 in all subjects with a directional DBS lead. Primary endpoint is based on double-blind testing of omnidirectional vs. directional DBS in randomized order at 3-month follow-up visit.
Treatment: Devices: Omnidirectional stimulation
At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional stimulation with the Infinity DBS lead.
Treatment: Devices: Directional stimulation
At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated using directional contacts at the best segmented level of the Infinity DBS lead.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Wider Therapeutic Window With Directional Programming (Superiority)
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Assessment method [1]
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Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control.
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Timepoint [1]
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3-month follow-up visit after initial programming
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Secondary outcome [1]
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Percentage of Participants With Wider Therapeutic Window With Directional Programming (Non-inferiority)
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Assessment method [1]
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Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. The proportion of subjects with wider therapeutic window using directional stimulation will be compared to a performance goal of 60% with a non-inferiority threshold of 40%. Based on randomized, double-blind evaluation using within-subject control.
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Timepoint [1]
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3-month follow-up visit after initial programming
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Secondary outcome [2]
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Change in UPDRS III Score on and Off Stimulation (Medication on) at 3 and 6 Months
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Assessment method [2]
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Change with stimulation on vs. off in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination at 3 months using omnidirectional stimulation, compared to 6 months using directional stimulation. UPDRS part III contains 27 questions used to measures severity of Parkinson's motor symptoms. The range of scores is 0 to 108, with higher score indicating greater symptoms. Subjects are on medication for the assessment.
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Timepoint [2]
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3-month and 6-month follow-up visits
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Eligibility
Key inclusion criteria
- Subject is able to provide informed consent;
- Subject is diagnosed with Parkinson's disease (PD) and has been recommended to receive
an Infinity DBS system with a bilateral DBS implant in the Subthalamic Nucleus (STN),
or has received an implant of an Infinity system with bilateral lead implants in the
STN;
- Subject must be available for follow-up visits.
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Minimum age
No limit
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Maximum age
No limit
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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
- Subject is not a surgical candidate;
- In the investigator's opinion, the subject is unable to tolerate multiple programming
sessions within a single setting;
- Subject is unable to comply with the follow-up schedule.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/01/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/04/2022
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Sample size
Target
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Accrual to date
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Final
234
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [2]
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Royal Melbourne Hospital, Department of Neurology - Melbourne
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Royal Melbourne Hospital - Melbourne
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Westmead Hospital - Richmond
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Recruitment postcode(s) [1]
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4102 - Brisbane
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Recruitment postcode(s) [2]
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3050 - Melbourne
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Recruitment postcode(s) [3]
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2145 - Richmond
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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Florida
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Illinois
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Kansas
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Ohio
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Texas
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Belgium
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Gent
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Germany
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Mainz
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Germany
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Dresden
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Germany
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Düsseldorf,
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Germany
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Düsseldorf
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Germany
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Hamburg
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Germany
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Regensburg
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Milano
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Italy
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Pavia
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Italy
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Udine
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Poland
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Gdansk
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Poland
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Warsaw
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Spain
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Badalona
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Spain
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Oviedo
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Spain
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this post-market study is to characterize the clinical performance of the
Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator
(IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller
and related system components.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02989610
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Alfons Schnitzler, MD
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Address
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Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02989610
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