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Clinical Evaluation of the Infinity Deep Brain Stimulation System (PROGRESS)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Omnidirectional stimulation
Directional stimulation
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sacramento Medical Center
  • University of Colorado Hospital
  • Shands at University of Florida
  • University of Miami Hospital
  • Rush University, Department of Neurological Sciences
  • Kansas University Medical Center
  • Johns Hopkins University Hospital
  • Robert Wood Johnson University Hospital
  • Albany Medical Center
  • New York University Langone Medical Center
  • Mount Sinai Hospital, New York, Department of Neurology
  • Mount Sinai Hospital
  • The Cleveland Clinic Foundation
  • Oregon Health & Science University
  • Oregon Health and Science University, Department of Neurology
  • St. Luke's Hospital & Health Network
  • Pennsylvania Hospital
  • Thomas Jefferson University Hospital
  • Allegheny General Hospital
  • Neurology Consultants of Dallas
  • CHI St. Luke's Health Baylor College
  • Abbott, Medical and Clinical Affairs
  • Princess Alexandra Hospital
  • Royal Melbourne Hospital, Department of Neurology
  • Royal Melbourne Hospital
  • Westmead Hospital
  • UZ Gent
  • Johannes Gutenberg University of Mainz, Department of Neurosurgery
  • Universitätsklinikum Carl Gustav Carus Dresden
  • Heinrich Heine University of Düsseldorf, Department of Neurology
  • Heinrich Heine University of Düsseldorf, Department of Neurology
  • Heinrich Heine University of Düsseldorf, Department of Neurosurgery
  • Heinrich Heine University of Düsseldorf, Department of Neurology
  • Medizinische Einrichtungen der Universität Düsseldorf
  • University Medical Centre Hamburg, Department of Neurology,
  • UKE Hamburg
  • Johannes Gutenberg-University of Mainz
  • Klinikum der Universität Regensburg
  • IRCCS Istituto Ortopedico Galeazzi
  • Fondazione Istituto Neurologico Nazionale C. Mondino
  • Azienda Ospedaliero-Universitaria S Maria della Misericordia
  • Copernicus Hospital, Department of Neurosurgery,
  • Institute of Psychiatry and Neurology
  • Hospital Trias i Pujol, Department of Neurology
  • Hospital Trias i Pujol
  • Hospital Universitario Central de Asturias
  • Hospital Universitario Central de Asturias, Department of Neurology,
  • Hospital Universitario Virgen del Rocío, Department of Neurology
  • Hospital Universitario Virgen del Rocío, Department of Neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omnidirectional followed by directional DBS

Arm Description

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 endpoint is based on double-blind testing of omnidirectional vs. directional DBS in randomized order at 3-month follow-up visit.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 8, 2016
Last Updated
June 28, 2022
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02989610
Brief Title
Clinical Evaluation of the Infinity Deep Brain Stimulation System
Acronym
PROGRESS
Official Title
Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
August 7, 2019 (Actual)
Study Completion Date
April 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single-arm crossover study, with double-blind, randomized sequence of testing for primary endpoint. Although this was a crossover study, the primary endpoint was a double-blind randomized controlled assessment of therapeutic window during the 3-month clinic visit. Subjects received both directional and omnidirectional stimulation, and the order was randomized.
Masking
None (Open Label)
Masking Description
Single-arm, open-label design for overall study. Primary endpoint is based on double-blind, randomized testing of omnidirectional and directional DBS during three-month follow visit. Participants are blinded to all details of stimulation for first six months, including details of stimulation testing. Outcomes assessor is blinded to stimulation type for primary and secondary endpoints.
Allocation
N/A
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omnidirectional followed by directional DBS
Arm Type
Experimental
Arm Description
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 endpoint is based on double-blind testing of omnidirectional vs. directional DBS in randomized order at 3-month follow-up visit.
Intervention Type
Device
Intervention Name(s)
Omnidirectional stimulation
Intervention Description
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
Intervention Name(s)
Directional stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Wider Therapeutic Window With Directional Programming (Superiority)
Description
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.
Time Frame
3-month follow-up visit after initial programming
Secondary Outcome Measure Information:
Title
Percentage of Participants With Wider Therapeutic Window With Directional Programming (Non-inferiority)
Description
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.
Time Frame
3-month follow-up visit after initial programming
Title
Change in UPDRS III Score on and Off Stimulation (Medication on) at 3 and 6 Months
Description
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.
Time Frame
3-month and 6-month follow-up visits

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfons Schnitzler, MD
Organizational Affiliation
Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Vesper, MD
Organizational Affiliation
Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacramento Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
94229
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Shands at University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Rush University, Department of Neurological Sciences
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins University Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Hospital, New York, Department of Neurology
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Oregon Health and Science University, Department of Neurology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
St. Luke's Hospital & Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18018
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Neurology Consultants of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
CHI St. Luke's Health Baylor College
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Abbott, Medical and Clinical Affairs
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Princess Alexandra Hospital
City
Brisbane
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Melbourne Hospital, Department of Neurology
City
Melbourne
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
ZIP/Postal Code
3050
Country
Australia
Facility Name
Westmead Hospital
City
Richmond
ZIP/Postal Code
2145
Country
Australia
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
Johannes Gutenberg University of Mainz, Department of Neurosurgery
City
Mainz,
State/Province
Mainz
ZIP/Postal Code
55126
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
1815
Country
Germany
Facility Name
Heinrich Heine University of Düsseldorf, Department of Neurology
City
Düsseldorf,
ZIP/Postal Code
40210
Country
Germany
Facility Name
Heinrich Heine University of Düsseldorf, Department of Neurology
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Heinrich Heine University of Düsseldorf, Department of Neurosurgery
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Heinrich Heine University of Düsseldorf, Department of Neurology
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Medizinische Einrichtungen der Universität Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
University Medical Centre Hamburg, Department of Neurology,
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
UKE Hamburg
City
Hamburg
Country
Germany
Facility Name
Johannes Gutenberg-University of Mainz
City
Mainz
Country
Germany
Facility Name
Klinikum der Universität Regensburg
City
Regensburg
Country
Germany
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milano
Country
Italy
Facility Name
Fondazione Istituto Neurologico Nazionale C. Mondino
City
Pavia
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria S Maria della Misericordia
City
Udine
Country
Italy
Facility Name
Copernicus Hospital, Department of Neurosurgery,
City
Gdańsk
Country
Poland
Facility Name
Institute of Psychiatry and Neurology
City
Warsaw
Country
Poland
Facility Name
Hospital Trias i Pujol, Department of Neurology
City
Badalona
ZIP/Postal Code
08917
Country
Spain
Facility Name
Hospital Trias i Pujol
City
Badalona
ZIP/Postal Code
08917
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
32762
Country
Spain
Facility Name
Hospital Universitario Central de Asturias, Department of Neurology,
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío, Department of Neurology
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío, Department of Neurology
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Evaluation of the Infinity Deep Brain Stimulation System

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