Clinical Evaluation of the Infinity Deep Brain Stimulation System

NCT ID: NCT02989610

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 234 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2022-04-19

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.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Omnidirectional stimulation

Intervention Type: DEVICE

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.

Directional stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfons Schnitzler, MD

Role: PRINCIPAL_INVESTIGATOR

Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience

Jan Vesper, MD

Role: PRINCIPAL_INVESTIGATOR

Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery

Locations

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

University of Miami Hospital

Miami, Florida, United States

Rush University, Department of Neurological Sciences

Chicago, Illinois, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Johns Hopkins University Hospital

Baltimore, Maryland, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Albany Medical Center

Albany, New York, United States

New York University Langone Medical Center - Tisch Hospital

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State Medical

Columbus, Ohio, United States

Oregon Health and Science University, Department of Neurology

Portland, Oregon, United States

St. Luke's Hospital & Health Network

Bethlehem, Pennsylvania, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania, United States

Neurology Consultants of Dallas

Dallas, Texas, United States

CHI St. Luke's Health Baylor College of Medicine Medical Center

Houston, Texas, United States

Abbott, Medical and Clinical Affairs

Plano, Texas, United States

Princess Alexandra Hospital

Brisbane, , Australia

Royal Melbourne Hospital - City Campus

Melbourne, , Australia

Westmead Hospital

Richmond, , Australia

UZ Gent

Ghent, , Belgium

Carl Gustav Carus Dresden an der Technischen

Dresden, , Germany

Heinrich Heine University of Düsseldorf, Department of Neurology

Düsseldorf, , Germany

Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery

Düsseldorf, , Germany

UKE Hamburg

Hamburg, , Germany

Johannes Gutenberg-University of Mainz

Mainz, , Germany

Klinikum der Universität Regensburg

Regensburg, , Germany

IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Fondazione Istituto Neurologico Nazionale C. Mondino

Pavia, , Italy

Azienda Ospedaliero-Universitaria S Maria della Misericordia

Udine, , Italy

Copernicus Hospital, Department of Neurosurgery,

Gdansk, , Poland

Oncology Center- Marie Curie Institute

Warsaw, , Poland

Institute of Psychiatry and Neurology

Warsaw, , Poland

Hospital Universitari Germans Trias I Pujol

Badalona, , Spain

Hospital Universitario Central de Asturias, Department of Neurology,

Oviedo, , Spain

Hospital Universitario Virgen del Rocío, Department of Neurology

Seville, , Spain

The Walton Centre

Liverpool, , United Kingdom

Countries

United States; Australia; Belgium; Germany; Italy; Poland; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SJM-CIP-10061

Identifier Type: -

Identifier Source: org_study_id