Clinical trial NCT02989610: Clinical Evaluation of the Infinity Deep Brain Stimulation System
Official title: Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: SJM-CIP-10061
PROGRESS
Infinity DBS
Parkinson Disease
UPDRS
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-12-12
Enrollment: 234
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Superiority)
timeFrame: 3-month follow-up visit after initial programming
Secondary outcomes:
measure: Percentage Of Participants With Wider Therapeutic Window With Directional Programming (Non-Inferiority)
timeFrame: 3-month follow-up visit after initial programming
measure: Change In UPDRS III Score On and Off Stimulation (Medication On) at 3 and 6 Months
timeFrame: 3 and 6 Months Follow-Up Visits
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Gainesville
country: United States
facility: Shands at University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Chicago
country: United States
facility: Rush University, Department of Neurological Sciences
state: Illinois
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital
state: Maryland
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: New York University Langone Medical Center - Tisch Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State Medical
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University, Department of Neurology
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Hospital & Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital - ASRI
state: Pennsylvania
city: Dallas
country: United States
facility: Neurology Consultants of Dallas
state: Texas
city: Houston
country: United States
facility: CHI St. Luke's Health Baylor College of Medicine Medical Center
state: Texas
city: Plano
country: United States
facility: Abbott, Medical and Clinical Affairs
state: Texas
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital - City Campus
city: Richmond
country: Australia
facility: Westmead Hospital
city: Gent
country: Belgium
facility: UZ Gent
city: Dresden
country: Germany
facility: Carl Gustav Carus Dresden an der Technischen
city: Düsseldorf
country: Germany
facility: Heinrich Heine University of Düsseldorf, Department of Neurology
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery
city: Hamburg
country: Germany
facility: UKE Hamburg
city: Mainz
country: Germany
facility: Johannes Gutenberg-University of Mainz
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Nazionale C. Mondino
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria S Maria della Misericordia
city: Gdańsk
country: Poland
facility: Copernicus Hospital, Department of Neurosurgery,
city: Warsaw
country: Poland
facility: Oncology Center- Marie Curie Institute
city: Warsaw
country: Poland
facility: Institute of Psychiatry and Neurology
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias, Department of Neurology,
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío, Department of Neurology
city: Liverpool
country: United Kingdom
facility: The Walton Centre
Study officials:
affiliation: Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience
name: Alfons Schnitzler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery
name: Jan Vesper, MD
role: PRINCIPAL_INVESTIGATOR
References: