Clinical Evaluation of the Infinity Deep Brain Stimulation System

Completed

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT02989610

Run by

Abbott Medical Devices

People needed

234

Starts

2017-01-31

Expected to finish

2022-04-19

Last updated by the study team

2024-08-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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