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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02989610




Registration number
NCT02989610
Ethics application status
Date submitted
8/12/2016
Date registered
12/12/2016

Titles & IDs
Public title
Clinical Evaluation of the Infinity Deep Brain Stimulation System
Scientific title
Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System
Secondary ID [1] 0 0
SJM-CIP-10061
Universal Trial Number (UTN)
Trial acronym
PROGRESS
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Omnidirectional stimulation
Treatment: Devices - Directional stimulation

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 end point is based on double-blind testing of omnidirectional vs. directional DBS in randomized order at 3-month follow-up visit.

In this Observational study design, all interventions here are therapeutic interventions that are part of the standard of care, rather than assigned as part of an interventional study.


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

Outcomes
Primary outcome [1] 0 0
Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority)
Timepoint [1] 0 0
3-month follow-up visit after initial programming
Secondary outcome [1] 0 0
Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority)
Timepoint [1] 0 0
3-month follow-up visit after initial programming
Secondary outcome [2] 0 0
Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months
Timepoint [2] 0 0
3 and 6 Months Follow-Up Visits

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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/04/2022
Sample size
Target
Accrual to date
Final
234
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - City Campus - Melbourne
Recruitment hospital [3] 0 0
Westmead Hospital - Richmond
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
3050 - Melbourne
Recruitment postcode(s) [3] 0 0
2145 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Germany
State/province [14] 0 0
Dresden
Country [15] 0 0
Germany
State/province [15] 0 0
Düsseldorf
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Germany
State/province [17] 0 0
Mainz
Country [18] 0 0
Germany
State/province [18] 0 0
Regensburg
Country [19] 0 0
Italy
State/province [19] 0 0
Milano
Country [20] 0 0
Italy
State/province [20] 0 0
Pavia
Country [21] 0 0
Italy
State/province [21] 0 0
Udine
Country [22] 0 0
Poland
State/province [22] 0 0
Gdansk
Country [23] 0 0
Poland
State/province [23] 0 0
Warsaw
Country [24] 0 0
Spain
State/province [24] 0 0
Badalona
Country [25] 0 0
Spain
State/province [25] 0 0
Oviedo
Country [26] 0 0
Spain
State/province [26] 0 0
Sevilla
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Liverpool

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
Alfons Schnitzler, MD
Address 0 0
Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02989610