NCT02989610|CompletedResultsFDA Device
Clinical Evaluation of the Infinity Deep Brain Stimulation System
PROGRESS
Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System
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Sponsor study identifier
observational
234
8 countries
41
Study Start
January 31, 2017
Actual (reported)Primary Completion
August 7, 2019
Actual (reported)Study Completion
April 19, 2022
Actual (reported)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. Participants in the PROGRESS study are not assigned to interventional therapy groups. Participants in the PROGRESS study are followed in an observational format as they receive omnidirectional and then directional DBS programming that is part of routine medical care. Data on symptoms are collected during two different stages of programming, and those outcomes compared to assess the effect of omnidirectional or directional programming.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 19, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 8, 2016
Actual (reported)December 12, 2016
Actual (reported)January 31, 2017
Actual (reported)August 7, 2019
Actual (reported)November 19, 2020
Actual (reported)April 19, 2022
Actual (reported)Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority)
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.
3-month follow-up visit after initial programming
Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority)
3-month follow-up visit after initial programming
Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months
3 and 6 Months Follow-Up Visits
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.
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.
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.
Subjects who have a diagnosis matching the approved indication and are being considered for a DBS implant or who have been implanted with an Infinity System comprise the target population for this study. All subjects who meet the inclusion and none of the exclusion criteria and have signed an Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent will be considered enrolled in the study.
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Shands at University of Florida
Gainesville, Florida, 32610, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Rush University, Department of Neurological Sciences
Chicago, Illinois, 60612, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins University Hospital
Alfons Schnitzler, MD
Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience
Jan Vesper, MD
Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery
234 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2016
First Posted
December 12, 2016
Study Start
January 31, 2017
Actual (reported)Automated Deep Brain Stimulation Programming Using Functional Mapping
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Baltimore, Maryland, 21287, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Albany Medical Center
Albany, New York, 12208, United States
New York University Langone Medical Center - Tisch Hospital
New York, New York, 10016, United States
Mount Sinai Hospital
New York, New York, 10019, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State Medical
Columbus, Ohio, 43210, United States
Oregon Health and Science University, Department of Neurology
Portland, Oregon, 97239, United States
St. Luke's Hospital & Health Network
Bethlehem, Pennsylvania, 18015, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, 15212, United States
Neurology Consultants of Dallas
Dallas, Texas, 75251, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas, 77030, United States
Abbott, Medical and Clinical Affairs
Plano, Texas, 75024, United States
Princess Alexandra Hospital
Brisbane, 4102, Australia
Royal Melbourne Hospital - City Campus
Melbourne, 3050, Australia
Westmead Hospital
Richmond, 2145, Australia
UZ Gent
Ghent, 42100, Belgium
Carl Gustav Carus Dresden an der Technischen
Dresden, 1307, Germany
Heinrich Heine University of Düsseldorf, Department of Neurology
Düsseldorf, 40225, Germany
Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery
Düsseldorf, Germany
UKE Hamburg
Hamburg, 20246, Germany
Johannes Gutenberg-University of Mainz
Mainz, 55131, Germany
Klinikum der Universität Regensburg
Regensburg, 93053, Germany
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161, Italy
Fondazione Istituto Neurologico Nazionale C. Mondino
Pavia, 27100, Italy
Azienda Ospedaliero-Universitaria S Maria della Misericordia
Udine, 33100, Italy
Copernicus Hospital, Department of Neurosurgery,
Gdansk, 80-803, Poland
Oncology Center- Marie Curie Institute
Warsaw, 02-781, Poland
Institute of Psychiatry and Neurology
Warsaw, 02-957, Poland
Hospital Universitari Germans Trias I Pujol
Badalona, 08916, Spain
Hospital Universitario Central de Asturias, Department of Neurology,
Oviedo, 33011, Spain
Hospital Universitario Virgen del Rocío, Department of Neurology
Seville, 41013, Spain
The Walton Centre
Liverpool, L9 7LJ, United Kingdom
Primary Completion
August 7, 2019
Actual (reported)Study Completion
April 19, 2022
Actual (reported)Last Updated
August 22, 2024
Results First Posted
November 19, 2020
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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