Clinical Evaluation of the Infinity Deep Brain Stimulation System

Parkinson Disease Clinical Trial

— PROGRESS  

Official title:

Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989610
• Other study ID #: SJM-CIP-10061
• Status: Completed
• Phase: N/A
• Start date: January 31, 2017
• Est. completion date: April 19, 2022

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: April 19, 2022
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane
Australia	Royal Melbourne Hospital	Melbourne
Australia	Royal Melbourne Hospital, Department of Neurology	Melbourne
Australia	Westmead Hospital	Richmond
Belgium	UZ Gent	Gent
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden
Germany	Heinrich Heine University of Düsseldorf, Department of Neurology	Düsseldorf
Germany	Heinrich Heine University of Düsseldorf, Department of Neurology	Düsseldorf
Germany	Heinrich Heine University of Düsseldorf, Department of Neurosurgery	Düsseldorf
Germany	Medizinische Einrichtungen der Universität Düsseldorf	Düsseldorf
Germany	Heinrich Heine University of Düsseldorf, Department of Neurology	Düsseldorf,
Germany	UKE Hamburg	Hamburg
Germany	University Medical Centre Hamburg, Department of Neurology,	Hamburg
Germany	Johannes Gutenberg-University of Mainz	Mainz
Germany	Johannes Gutenberg University of Mainz, Department of Neurosurgery	Mainz,	Mainz
Germany	Klinikum der Universität Regensburg	Regensburg
Italy	IRCCS Istituto Ortopedico Galeazzi	Milano
Italy	Fondazione Istituto Neurologico Nazionale C. Mondino	Pavia
Italy	Azienda Ospedaliero-Universitaria S Maria della Misericordia	Udine
Poland	Copernicus Hospital, Department of Neurosurgery,	Gdansk
Poland	Institute of Psychiatry and Neurology	Warsaw
Spain	Hospital Trias i Pujol	Badalona
Spain	Hospital Trias i Pujol, Department of Neurology	Badalona
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Universitario Central de Asturias, Department of Neurology,	Oviedo
Spain	Hospital Universitario Virgen del Rocío, Department of Neurology	Sevilla
Spain	Hospital Universitario Virgen del Rocío, Department of Neurology	Sevilla
United States	Albany Medical Center	Albany	New York
United States	University of Colorado Hospital	Aurora	Colorado
United States	Johns Hopkins University Hospital	Baltimore	Maryland
United States	St. Luke's Hospital & Health Network	Bethlehem	Pennsylvania
United States	Rush University, Department of Neurological Sciences	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Neurology Consultants of Dallas	Dallas	Texas
United States	Shands at University of Florida	Gainesville	Florida
United States	CHI St. Luke's Health Baylor College	Houston	Texas
United States	Kansas University Medical Center	Kansas City	Kansas
United States	University of Miami Hospital	Miami	Florida
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Mount Sinai Hospital	New York	New York
United States	Mount Sinai Hospital, New York, Department of Neurology	New York	New York
United States	New York University Langone Medical Center	New York	New York
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Abbott, Medical and Clinical Affairs	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	Oregon Health and Science University, Department of Neurology	Portland	Oregon
United States	Sacramento Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Germany,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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