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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Omnidirectional stimulation; Device: Directional stimulation

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia, 4102
    • Princess Alexandra Hospital
  • Melbourne, Australia, 3050
    • Royal Melbourne Hospital, Department of Neurology
  • Melbourne, Australia, 3050
    • Royal Melbourne Hospital
  • Richmond, Australia, 2145
    • Westmead Hospital
• Belgium
  • Gent, Belgium
    • UZ Gent
• Germany
  • Dresden, Germany, 1815
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Düsseldorf, Germany
    • Medizinische Einrichtungen der Universität Düsseldorf
  • Düsseldorf, Germany, 40210
    • Heinrich Heine University of Düsseldorf, Department of Neurology
  • Düsseldorf, Germany, 40210
    • Heinrich Heine University of Düsseldorf, Department of Neurosurgery
  • Düsseldorf, Germany, 40225
    • Heinrich Heine University of Düsseldorf, Department of Neurology
  • Düsseldorf,, Germany, 40210
    • Heinrich Heine University of Düsseldorf, Department of Neurology
  • Hamburg, Germany
    • UKE Hamburg
  • Hamburg, Germany, 20251
    • University Medical Centre Hamburg, Department of Neurology,
  • Mainz, Germany
    • Johannes Gutenberg-University of Mainz
  • Regensburg, Germany
    • Klinikum der Universität Regensburg
  • Mainz
    • Mainz,, Mainz, Germany, 55126
      • Johannes Gutenberg University of Mainz, Department of Neurosurgery
• Italy
  • Milano, Italy
    • IRCCS Istituto Ortopedico Galeazzi
  • Pavia, Italy
    • Fondazione Istituto Neurologico Nazionale C. Mondino
  • Udine, Italy
    • Azienda Ospedaliero-Universitaria S Maria della Misericordia
• Poland
  • Gdańsk, Poland
    • Copernicus Hospital, Department of Neurosurgery,
  • Warsaw, Poland
    • Institute of Psychiatry and Neurology
• Spain
  • Badalona, Spain, 08917
    • Hospital Trias i Pujol, Department of Neurology
  • Badalona, Spain, 08917
    • Hospital Trías i Pujol
  • Oviedo, Spain, 32762
    • Hospital Universitario Central de Asturias
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias, Department of Neurology,
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío, Department of Neurology
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocío, Department of Neurology
• United States
  • California
    • Sacramento, California, United States, 94229
      • Sacramento Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
  • Florida
    • Gainesville, Florida, United States, 32608
      • 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, 20814
      • 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, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10016
      • New York University Langone Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai Hospital, New York, Department of Neurology
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University, Department of Neurology
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18018
      • St. Luke's Hospital & Health Network
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15243
      • Allegheny General Hospital
  • Texas
    • Dallas, Texas, United States, 75251
      • Neurology Consultants of Dallas
    • Houston, Texas, United States, 77030
      • CHI St. Luke's Health Baylor College
    • Plano, Texas, United States, 75024
      • Abbott, Medical and Clinical Affairs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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)	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)	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	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-month and 6-month follow-up visits

Collaborators and Investigators

• 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

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 (Estimate): December 12, 2016

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• 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