Clinical Evaluation of the Infinity Deep Brain Stimulation System (PROGRESS)

April 2, 2024 updated by: Abbott Medical Devices

Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia, 4102
        • Princess Alexandra Hospital
      • Melbourne, Australia, 3050
        • Royal Melbourne Hospital - City Campus
      • Richmond, Australia, 2145
        • Westmead Hospital
  • Belgium
      • Gent, Belgium, 42100
        • UZ Gent
  • Germany
      • Dresden, Germany, 1307
        • Carl Gustav Carus Dresden an der Technischen
      • Düsseldorf, Germany, 40225
        • Heinrich Heine University of Düsseldorf, Department of Neurology
      • Düsseldorf, Germany
        • Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery
      • Hamburg, Germany, 20246
        • UKE Hamburg
      • Mainz, Germany, 55131
        • Johannes Gutenberg-University of Mainz
      • Regensburg, Germany, 93053
        • Klinikum der Universität Regensburg
  • Italy
      • Milano, Italy, 20161
        • IRCCS Istituto Ortopedico Galeazzi
      • Pavia, Italy, 27100
        • Fondazione Istituto Neurologico Nazionale C. Mondino
      • Udine, Italy, 33100
        • Azienda Ospedaliero-Universitaria S Maria della Misericordia
  • Poland
      • Gdańsk, Poland, 80-803
        • Copernicus Hospital, Department of Neurosurgery,
      • Warsaw, Poland, 02-781
        • Oncology Center- Marie Curie Institute
      • Warsaw, Poland, 02-957
        • Institute of Psychiatry and Neurology
  • Spain
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias, Department of Neurology,
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío, Department of Neurology
  • United Kingdom
      • Liverpool, United Kingdom, L9 7LJ
        • The Walton Centre
  • United States
    • California
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Sacramento Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands at University of Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University, Department of Neurological Sciences
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University Hospital
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • New York, New York, United States, 10019
        • Mount Sinai Hospital
      • New York, New York, United States, 10016
        • New York University Langone Medical Center - Tisch Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State Medical
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University, Department of Neurology
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Hospital & Health Network
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital - ASRI
    • Texas
      • Dallas, Texas, United States, 75251
        • Neurology Consultants of Dallas
      • Houston, Texas, United States, 77030
        • CHI St. Luke's Health Baylor College of Medicine Medical Center
      • Plano, Texas, United States, 75024
        • Abbott, Medical and Clinical Affairs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority)
Time Frame: 3-month follow-up visit after initial programming
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority)
Time Frame: 3-month follow-up visit after initial programming
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.
3-month follow-up visit after initial programming
Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months
Time Frame: 3 and 6 Months Follow-Up Visits
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.
3 and 6 Months Follow-Up Visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Alfons Schnitzler, MD, Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience
  • Principal Investigator: Jan Vesper, MD, Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2017

Primary Completion (Actual)

August 7, 2019

Study Completion (Actual)

April 19, 2022

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (Estimated)

December 12, 2016

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJM-CIP-10061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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