Clinical Evaluation of the Infinity Deep Brain Stimulation System

Completed

Conditions: Parkinson Disease

Interventions: Device: Omnidirectional stimulation
Device: Directional stimulation

Registration Number: NCT02989610

Lead Sponsor: Abbott Medical Devices

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.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 234

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Omnidirectional followed by directional DBS	Omnidirectional stimulation	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.
Omnidirectional followed by directional DBS	Directional stimulation	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.

Primary Outcome Measures

Name	Time	Method
Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority)	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.

Secondary Outcome Measures

Name	Time	Method
Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months	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.
Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority)	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.

Trial Locations

Locations (41): Pennsylvania Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Neurology Consultants of Dallas
🇺🇸
Dallas, Texas, United States
Robert Wood Johnson University Hospital
🇺🇸
New Brunswick, New Jersey, United States
UZ Gent
🇧🇪
Gent, Belgium
Institute of Psychiatry and Neurology
🇵🇱
Warsaw, Poland
University of Miami Hospital
🇺🇸
Miami, Florida, United States
Thomas Jefferson University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Allegheny General Hospital - ASRI
🇺🇸
Pittsburgh, Pennsylvania, United States
Oncology Center- Marie Curie Institute
🇵🇱
Warsaw, Poland
Fondazione Istituto Neurologico Nazionale C. Mondino
🇮🇹
Pavia, Italy
Johannes Gutenberg-University of Mainz
🇩🇪
Mainz, Germany
Royal Melbourne Hospital - City Campus
🇦🇺
Melbourne, Australia
Johns Hopkins University Hospital
🇺🇸
Baltimore, Maryland, United States
Ohio State Medical
🇺🇸
Columbus, Ohio, United States
Kansas University Medical Center
🇺🇸
Kansas City, Kansas, United States
IRCCS Istituto Ortopedico Galeazzi
🇮🇹
Milano, Italy
Azienda Ospedaliero-Universitaria S Maria della Misericordia
🇮🇹
Udine, Italy
Hospital Universitari Germans Trias I Pujol
🇪🇸
Badalona, Spain
Mount Sinai Hospital
🇺🇸
New York, New York, United States
Klinikum der Universität Regensburg
🇩🇪
Regensburg, Germany
UKE Hamburg
🇩🇪
Hamburg, Germany
Princess Alexandra Hospital
🇦🇺
Brisbane, Australia
Heinrich Heine University of Düsseldorf, Department of Neurology
🇩🇪
Düsseldorf, Germany
Albany Medical Center
🇺🇸
Albany, New York, United States
Abbott, Medical and Clinical Affairs
🇺🇸
Plano, Texas, United States
Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery
🇩🇪
Düsseldorf, Germany
Rush University, Department of Neurological Sciences
🇺🇸
Chicago, Illinois, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center
🇺🇸
Houston, Texas, United States
New York University Langone Medical Center - Tisch Hospital
🇺🇸
New York, New York, United States
Westmead Hospital
🇦🇺
Richmond, Australia
Hospital Universitario Virgen del Rocío, Department of Neurology
🇪🇸
Sevilla, Spain
St. Luke's Hospital & Health Network
🇺🇸
Bethlehem, Pennsylvania, United States
Carl Gustav Carus Dresden an der Technischen
🇩🇪
Dresden, Germany
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Copernicus Hospital, Department of Neurosurgery,
🇵🇱
Gdańsk, Poland
Hospital Universitario Central de Asturias, Department of Neurology,
🇪🇸
Oviedo, Spain
The Walton Centre
🇬🇧
Liverpool, United Kingdom
Kaiser Permanente Sacramento Medical Center
🇺🇸
Sacramento, California, United States
University of Colorado Hospital
🇺🇸
Aurora, Colorado, United States
Shands at University of Florida
🇺🇸
Gainesville, Florida, United States
Oregon Health and Science University, Department of Neurology
🇺🇸
Portland, Oregon, United States